Hospital beds: Dynamis and Gerialit with Dewert electrical control systems.
Specific models numbers manufactured from October 1995 to June 2001 inclusive.
Dynamis and Gérialit beds were manufactured with electrical control systems supplied by either Dewert or SKF.
This notification applies only to
Dewert
systems, which are easily recognizable by the design of the lockout unit, as shown in the manufacturer’s Field Safety Notice, MOD 466.
Affected model numbers: LI146B1—LI146BI, LI146D1—LI146DI, LI147B1—LI147D1, LI150A0—LI150B0, LI163B1—LI163C1, PRS0128, PRS0199, PRS0201, PRS2001.
Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface. Manufactured by Hill-Rom.
Models N02050, N02051, P02062, P02063, P02064 and P02065.
All serial numbers are affected
Storm 3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare.
All Storm3, Storm TT, Typhoon and Typhoon II powered wheelchairs purchased before 21 July 2008.
Orthopaedic instrument.
Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI).
The flexible handle is used during the insertion of the universal tibial nail, and femoral universal nail and the extraction of all universal nails.
All devices of the old design, where the handles are perpendicular to the threaded section, are affected by this recall - see figures below for a visual comparison of the old and new design.
The affected flexible handle (part no. 355.280) is always attached to the hammer guide (part no. 355.220).
Ambulatory insulin infusion pumps.
Animas IR1200, Animas IR1250 and Animas 2020.
All serial numbers
.
Animas no longer distributes the IR1200, IR1250 or the 2020 models in the UK. Affected pumps will be replaced with a different model of Animas insulin infusion pump. Animas will be providing training on the use of the replacement pumps.
The manufacturer considers pumps that are outside the warranty period to have exceeded their expected life, and so will only be providing free-of-charge replacements for pumps that are still within warranty on 31 December 2015.
Please note that all IR1200 and IR1250 pumps will be out of warranty by 31 December 2015.
Metal-on-metal (MoM) total hip replacements:
ADEPT® 12/14 modular head
All lots.
The ADEPT® 12/14 modular head used in MoM total hip arthroplasty, manufactured by Finsbury Orthopaedics Ltd. Finsbury was acquired by DePuy in December 2009. This device was commercially available from Finsbury or DePuy from 2004 to September 2011.
Note: This alert does not apply to ADEPT® hip resurfacing femoral components, which are not implanted in total hip arthroplasty procedures.
External fixators.
Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large)
Specific part numbers affected.
Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes).
Adept acetabular cups (48mm and 52mm).
Affected UK lot codes (see appendix).
Diacap® Ultra dialysis fluid filter.
Product code: 7107366.
All devices that are more than 10 months from the date of manufacture are affected.
This device is used as a bacteria and pyrogen filter for dialysis fluid purification, as well as for processing substitution solution for online haemodiafiltration and haemofiltration procedures.
The date on the label is in the format YYYY-MM e.g. 2012-07 for July 2012.
The month of manufacture in this case is July 2012 which should be counted as month one when calculating the age of filters.
Therefore, product manufactured in July 2012 should not be used after April 2013.
See
Field Safety Notice
for further information.
RÜSCH Macintosh laryngoscopes.
Disposable laryngoscope metal kit, disposable laryngoscope battery handles and reusable laryngoscope handles.
Distributed in the UK by Teleflex (RÜSCH).
Specific lot numbers are affected.
Disposable laryngoscope metal kit, catalogue numbers: 670160-0000** and 670190-0000**
Disposable laryngoscope battery handles, catalogue numbers: 670195-0000**
Reusable laryngoscope handles, catalogue numbers: 670067-0000**
** relates to blade size.
The lot numbers of affected products are as follows:
Disposable
Reusable
031511
031511
040811
041511
041511
040811
011012
123011
020712
011012
021512
030812
030812
032112
032112
073012
040412
083112
040912
103112
042712
111512
052912
Any product without a visible lot number should be treated as an affected product.
RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes).
Catalogue numbers: 670160-0000**
(** relates to blade size).
Batch numbers 041511 and 021512.
Distributed in the UK by Teleflex (RUSCH).
These laryngoscope handles are found in the RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes) – ensure both components of the kit are returned to Teleflex.
Teleflex issued a Field Safety Notice on
29 May 2012
regarding this product recall.
M.A. Arain & Brothers (PVT) Ltd issued two of their own Field Safety Notices, published in
April
and
May
2012.
Rad-8 Pulse Oximeter with 20-pin patient cable connector.
Manufactured from 27 March 2009 to 24 January 2013 inclusive.
Specific serial numbers are affected.
Legendair and Supportair Portable Ventilators.
Specific ventilator codes (see FSN).
Supplied by Airox and Covidien.
These ventilators are designed primarily for use by patients at home.
The affected ventilator codes are as follows:
Legendair™ Single Branch
4095700
-
INTL LEGENDAIR SINGLE BRANCH
4095701 - GB NO LEGENDAIR SINGLE BRANCH
4095702 - DE LEGENDAIR SINGLE BRANCH
4095705 - CA LEGENDAIR SINGLE BRANCH
4095706 - JP LEGENDAIR SINGLE BRANCH
4095709 - DK LEGENDAIR SINGLE BRANCH
4095721 - AU LEGENDAIR SINGLE BRANCH
Legendair™ Double Branch
4095900 - INTL LEGENDAIR DOUBLE BRANCH
4095901 - GB NO LEGENDAIR DOUBLE BRANCH
4095902 - DE LEGENDAIR DOUBLE BRANCH
4095905 - CA LEGENDAIR DOUBLE BRANCH
4095906 - JP LEGENDAIR DOUBLE BRANCH
4095909 - DK LEGENDAIR DOUBLE BRANCH
4095921 - AU LEGENDAIR DOUBLE BRANCH
Supportair™
4096200 - INTL SUPPORTAIR
4096201 - GB SUPPORTAIR
4096202 - DE SUPPORTAIR
Medtronic implantable defibrillators, models: Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277.
There are 805 potentially affected devices manufactured by Medtronic before April 2003 that have been distributed in the UK, 791 of which are believed to be still implanted. These include 289 Marquis VR 7230 devices, 402 Marquis DR 7274 devices and 100 InSync Marquis 7277 devices with serial numbers within the following ranges:
Growth hormone pens.
NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®.
NordiPen®
NordiPenMate®
All devices with a lot number beginning with A or B.
Lot numbers beginning with a ‘C’ are referred to in the July 2013 FSN but they were never distributed by the manufacturer.
How to find the lot number
The lot number is located on the mechanical section below the push button and can be exposed by turning the dose selector clockwise.
The lot number in the example image begins with ‘B’.
Kimba Spring paediatric buggies manufactured by Otto Bock.
All Kimba Spring paediatric buggies with the following part number(s): HR32901000 (size 1 rigid), HR32911000 (size 1 swivelled) and HR32931000 (size 2 swivelled) supplied between April 2003 and April 2007. Size 1 is intended for children aged approximately 1 to 6 years; size 2 for children aged 4 to 10 years.
Suction canisters and liners.
All Receptal:
1 litre canisters (List number 43449),
1 litre PVC liners (List number OL212) and
1 litre PE liners (List number OL213).
All batch numbers are affected.
The Receptal system is a closed, disposable suction system that is used to isolate suction waste. It is used
with adult, paediatric and neonatal patients.
Update to MDA/2013/026
Recall of Hospira 1 litre suction canisters and liners - additional products recalled.
Suction canisters and liners with Abbott labels and list numbers are now included in the recall.
One litre suction canisters - Abbott list number 770462.
One litre suction liners - Abbott list numbers L212A52 and L213A52.
All batch numbers are affected.
The affected products are part of a closed, disposable suction system that is used to isolate suction waste. They are used for adult, paediatric and neonatal patients.
Hospira has issued an updated
Field Safety Notice
(dated 7 June 2013) to extend the recall detailed in
MDA/2013/026
, to include 1 litre devices supplied under the legacy Abbott model numbers.
The Abbott labelled products are no longer in production, but may still be in stock.
The Abbott and Receptal products are manufactured to the same design and both are, therefore, affected. To clarify, the full list of devices affected by this problem is:
Receptal 1 litre canisters (List number 43449), previously marketed as Abbott 1L suction canisters (List number 770462)
Receptal 1 litre PVC liners (List number OL212), previously marketed as Abbott 1L suction liners (List number L212A52)
Receptal 1 litre PE liners (List number OL213), previously marketed as Abbott 1L suction liners (List number L213A52).