Vacutainer® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected.
All BD Vacutainer multiple sample Luer adaptors catalogue number 367300, NHS Supply Chain Code KFK036 (England only), which have a lot number that falls within the following numerical range (inclusive) are affected:
Lot number
1326169
, expiry date 11/2014
to
lot number
3072890
, expiry date 03/2016
Note
: This does not affect any other BD products which have a lot number within this range.
Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails
Specific serial numbers are affected.
General purpose volumetric infusion pumps intended for acute and sub-acute applications.
Product codes: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G.
The serial numbers of affected pumps are specific to each customer.
Contact your local biomedical engineering department to obtain this list or contact CareFusion directly to determine which pumps are affected.
The serial number is printed on the back of each pump.
The MHRA does
not
possess a list of affected serial numbers.
BD Neoflon™ IV cannula
All lots of:
Product code: 391350, size: 24 G, NHSSC code: FSP070
Product code: 391349, size: 26 G.
This is a disposable device designed to gain access to peripheral veins of the patient’s blood system for rehydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes. This device is intended for use on neonatal, paediatric and geriatric patients.
Single-use syringes: Plastipak
TM
50ml Luer Lok
Product codes affected: 300223 non sterile, 300865 sterile (NHS Supply Chain code FWC034 England only), 300869 Amber – sterile.
All lot numbers are affected.
Stock of the new design (with lower plunger forces) can be identified by an ‘N’ preceding the product code for example: N Ref 300865
Alaris® SmartSite® needle-free valve
Product reference: 2000E7D
Specific lot numbers
The Smartsite is a needle-free IV access device. Affected devices are made from a polycarbonate material.
The affected lot numbers are:
13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316.
If relevant to you, the national supply codes are as follows:
England NPC: FSW165
Scotland SKU: 066032
Northern Ireland BSO: does not have a PALS reference number
Wales NSV: FSN342
Only product code 2000E7D is affected and other configurations or item numbers are not affected.
This Medical Device Alert does not affect CareFusion’s MaxPlus or MaxZero needle-free connectors.
Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile.
Product code 300865 (England only - NHS Supply Chain code FWC034).
Specific lot numbers are affected.
Affected lot numbers:
Workstation software for computed tomography systems:
Vitrea CT Brain Perfusion 2D application.
Versions 6.0 and above for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced and Vitrea fX are affected.
Workstation software for computed tomography systems:
VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5).
Workstation software for computed tomography systems:
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3.
Peristeen Anal Irrigation System manufactured by Coloplast Limited.
The following Peristeen product codes contain rectal catheters:
29121 – Peristeen Anal Irrigation System (contains two rectal catheters)
29122 – Accessory Unit (contains 15 rectal catheters and one bag)
29123 – 10 rectal catheters
29126 – Peristeen Anal Irrigation System (contains two rectal catheters - small)
29127 – Accessory Unit (contains 15 rectal catheters – small and one bag)
29128 – 10 rectal catheters – small
Peristeen anal irrigation system manufactured by Coloplast Limited.
The instructions for use have been updated in response to publication of the review article ’Concensus review of best practice of transanal irrigation in adults’.
Consensus review of best practice of transanal irrigation in adults
(external link)
Ultrasound probe cover: Burr hole probe cover with gel.
These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment.
Product reference (SKU number): 3688UK, PC3688, PC3688EU.
Affected batch numbers are listed in the
Field Safety Notice
(FSN).
Note
that product ref (SKU number) 3688 is listed in the FSN but it is
not
for sale in the UK.
Basin/bowl liner or equipment cover (drape).
Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B.
All lot numbers.
These products (a type of surgical drape) are manufactured by Microtek Medical, but may be distributed by other companies. These devices will have been supplied in procedure packs. See page 5 of the manufacturer’s
FSN
for full product descriptions.
All devices manufactured since August 2009 are affected by this recall.
Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (formerly Datex-Ohmeda).
Also distributed by Baxter Healthcare.
This is an electronic vaporiser that was designed specifically for the delivery of Desflurane anaesthetic agent. It heats Desflurane to maintain constant temperature and vapour pressure for consistent output. It has an LED display which indicates vaporiser status (no output; low agent; warm-up; operational; and alarm battery low).
All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens).
The Servo ventilators 300 (SV300) and 300A (SV300A) are intended for general and critical care ventilation of adult, paediatric and neonatal patients.
Affected ventilators are those with an automode function. Automode is a function where two consecutive breathing efforts from the patient will shift the ventilator status from control mode to a support mode. The ventilator will remain in the support mode as long as the patient keeps breathing; if the patient stops breathing the ventilator will shift back to the control mode.
The Servo-I ventilator is not affected by this issue.
Overhead and Mobile Patient Hoists:
Standard Sling Bar 450 (Spreader bar).
Specific models numbers.
Manufactured By Liko
(A Hill-Rom Company).
Affected Devices:
Standard Sling Bar 450, product numbers: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, or 5019013.
Distributed from January 1980 to November 2012 inclusive
The above sling bar product numbers may be assembled with Golvo 1000, 3000 and 7000 series lifts, Viking M, Viking L, LikoLight 100 & 125, Caroli 101 and Uno 100, 101 & 102.