Intravenous pump set: Lifeshield Primary Plumset. Specific list numbers and lot numbers are affected. List number Lot numbers Set description 14000-92-28 27112-5H 30079-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Prepierced Y-site, 272 cm 14001-92-38* 28187-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Clave port, Clave Y-site, 272 cm *the equivalent NHS Supply Chain code for this list number is FSB1314 (England only). NHS Supply Chain has sent its own customer notice about this recall (reference NHS SC 32).

Intravenous administration sets: Primary PlumSet Clave secondary port. Specific list numbers are affected. All lots manufactured after July 2007 of the following list numbers have been supplied to the UK and are affected: 140010728 140018328 140019228 140149228 142129228 196735324 Note that any other list numbers detailed in the FSN have not been supplied to the UK

Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.

GemStar docking station for use with specific GemStar infusion pumps. The specific products potentially affected by the two problems are shown below: Affected product (docking station list numbers) Issue Potential to occur in conjunction with products 13075-XX-07 13075-XX-09 Pump fails to power up Gemstar phase 3 pump (13000-XX, 13100-XX, 13150-XX) Error code 11/003 on pump and infusion stops Gemstar phase 4 pump (13086-XX, 13087-XX, 13088-XX) External battery pack (13073-XX) If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification. There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert MDA/2013/078 .

Receptal suction canisters and liners. All Abbott and Hospira list numbers are affected. All lot numbers and sizes are affected. This is a closed, disposable system that is used to isolate suction waste. It is used with adult, paediatric and neonatal patients. Hospira has only been able to provide the Abbott list numbers for the 1 litre liners and canisters.

General Hospital and Personal Use Devices

Neonatal and paediatric support devices. All batches of: Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2. These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The part number is printed on the product itself.

HeartStart MRx defibrillator/monitor. Model numbers M3535A and M3536A with Q-CPR™ meter option B08. Specific serial numbers affected. Affected MRx units have to meet all of the three criteria below: serial numbers from US00100153 to US00571587 inclusive the Q-CPR Meter Option B08 installed Software revision F.xx, R.xx, T.00.00 or T.00.01 installed

General Hospital and Personal Use Devices

Neonatal and paediatric support devices Gel-E Donut, part numbers: 92025-A, 92025-B, 92025-C Squishon 2, part number: 91033-2 All batches These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The part number is printed on the product itself.

Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’.

HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Distributed by Philips and Cardiac Services UK & Ireland. NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.

S74 Elite Sport Scooter with Leoch 20 amp/hour batteries Specific serial numbers. The following serial numbers are affected. SG211113017FVO – SG211113148FVO inclusive SG216713002FVO – SG216713169FVO inclusive SG219313286FVO – SG219313335FVO inclusive SG219313114FVO – SG219313211FVO inclusive

Powered wheelchairs manufactured by Pride Mobility Products Ltd. All models suitable for occupied use in vehicles are affected.

Home use blood glucose meters: Accu-Chek Compact meter and test strips Accu-Chek Mobile meter and test cassette Accu-Chek Active meter and test strips manufactured by Roche.

Home use blood glucose meters. Accu-Chek Mobile meter and Accu-Chek Mobile test cassette manufactured by Roche.

Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi, supplied by Roche. Multiple tests are affected, including syphilis (TPLA) test made by Sekisui. All reagents are supplied by Roche. The analyser can run assays that are: manufactured by Roche manufactured by third parties and supplied by Roche – ‘partnership assays’ (eg TPLA) Affected assays include those requiring manual handling that are listed in the Roche Field Safety Notice

FRED easy Defibrillators manufactured by Schiller. All devices are affected. Devices are distributed by Amazon Medical Ltd. Affected defibrillators: NOTE: FRED easyport is not affected Product All models Article number FRED easy Basic REF BR-FREDEASY FRED easy ECG on-screen REF BR-FREDEE FRED easy Manual REF BR-FREDEEM

Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik. All (Paediatric and Adult) devices are affected. Devices are distributed by Amazon Medical Ltd. The electrodes (example, right) are supplied with the FRED defibrillators or can be acquired as an accessory. All those electrodes produced before January 2011 are affected. SCHILLER FRED AED: Defibrillation Electrodes - Nessler Medizintechnik Product Article number FRED defibrillation electrodes Adult REF W1410241 FRED defibrillation electrodes Child Same packet – labelled Child REF W1410262 Schiller Fred easyport, APLC1 & APLC2 Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easyport defibrillation electrodes - Adult Same size packet as 2.155057 REF 2.155056 FRED easyport defibrillation electrodes - Child REF 2.155057 APLC1 & APLC2 defibrillation electrodes Adult REF 0‐21‐0024 Schiller Fred easy Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easy defibrillation electrodes REF 0-21-0003 FRED easy REF 0-21-0020 FRED easy REF 0-21-0000 FRED easy REF 0-21-0021 The Schiller electrodes are used with the following defibrillators/monitors manufactured by Schiller. Products FRED easy Basic FRED easy ECG on-screen FRED easy Manual FRED AED FRED easyport APLC1 FRED easyport APLC2 AT101 easy Argus Pro Lifecare 1 Argus Pro Lifecare 2

Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays. Laboratory analysers: ADVIA Centaur ® and ADVIA Centaur ® XP. Specific catalogue numbers. The following assay systems are affected by this alert: ADVIA Centaur system (Cat. 078-A001-xx) ADVIA Centaur refurbished (Cat. 078-A002R02) ADVIA Centaur XP system (Cat. 078-A011-03) ADVIA Centaur XP refurbished (Cat 078-A011R03)

SLE 4000/5000 ventilator. Power supply unit (PSU) model FP110-410. Specific serial numbers. Affected products can be identified as shown below: Affected product Ventilator model SLE 4000: Serial numbers 42040 and below Ventilator model SLE 5000: Serial numbers 53164 and below Power supply unit model FP110-410: Serial numbers from 163746 to 167558 inclusive Other model FP110-410 PSUs outside the above serial range may be affected if they contain ‘tall’ capacitors. These can be checked by following the recommendations in the manufacturer’s technical bulletin .

Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc. All lot numbers and all item codes distributed since 2006. Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate ligament (ACL) reconstruction. Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is currently investigating the cause of this problem. Most cases resolved without intervention. A small number of cases needed local debridement and removal of any remaining screw fragments, or replacement with an alternative screw or bone graft. The manufacturer estimates that about 2,550 devices have been used in the UK since 2006. The manufacturer is aware of seven reported cases of inflammation in the UK of which two required implant revision. The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who were known to use CALAXO about this product recall in August 2007 (see MHRA website). This notice is to facilitate the recall.

Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see Appendix for affected lot numbers in pdf only). BHR acetabular cups (46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 62mm, 64mm). Affected UK lot numbers (see Appendix in pdf only).

Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651.

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits. Specific product codes and lot numbers. If relevant to you, the national supply codes are as follows: Scotland SKU: Smiths code NDC code H4001PS 054220 H4001S 007424 H4002PS 014408 H4002S 039364 H4051 - H4052 - England NPC: use manufacturer’s codes in the FSN Northern Ireland: use manufacturer’s codes in the FSN Wales NSV: use manufacturer’s codes in the FSN

Tracheostomy tubes: Bivona®  Neonatal, Pediatric and Flextend. Lot numbers from 1631477 to 1923406 inclusive. Only devices intended for neonatal and paediatric use are affected. Only tubes with an integrated connector that does not allow for use of a disconnect wedge (TR3) are affected. Examples of accessories that can be used with the affected tubes include: speaking valves, heat moisture exchangers, and breathing circuit connectors. A design modification was implemented in November 2010 to address this problem.