Field Safety Notices: 4 to 8 March 2024
List of Field Safety Notices from 4 to 8 March 2024.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View . FSNs before this date are on the
Abbott: HeartMate Touch Communication SystemÌý
January 2024
Multiple active implantable device programmerÌý
Model: HMT1150 Ìý
MHRA reference: ÌýÌýÌý
Applied Medical: CA500, Epix UNIVERSAL CLIP APPLIER 3/BX
08 March 2024
Ligation clip, metallic
Model: CA500
MHRA reference: 2024/002/008/601/037
B Braun: NOVOSYNÌý
05 March 2024
Sutures, PolyglactinÌý
Model: C0068041N1
MHRA reference: ÌýÌýÌý
Baxter: PERI-GUARD; SUPPLE PERI-GUARDÌý
01 March 2024 FA-2024-008
MHRA reference: LetterÌýÌýÌýÌýÌý
MHRA reference: FSNÌýÌýÌýÌý ÌýÌýÌý
Baxter: PERI-GUARD; SUPPLE PERI-GUARD
01 March 2024 FA-2024-010
MHRA reference: LetterÌýÌýÌý
MHRA reference: FSNÌý ÌýÌýÌýÌý
Bio-Rad: Anti-k
20 February 2024
Anti-k (KEL002) red blood cell grouping IVD, antibÌý
Model: 50260
MHRA reference: Ìý
Covidien: Auto Suture Structural Balloon & Blunt Tip Trocar
March 2024
Laparoscopic multi-instrument access port
Model: OMS-T10SB, OMS-T10BTNL, OMS-T10BTSNL, OMS-T12BTNL, OMS-T10BT, OMS-T12BT, OMST10BTS
MHRA reference: 2024/003/004/601/032
Draeger: Perseus A500Ìý
March 2024
Anesthesia Units
MHRA reference: Ìý
Epic Systems Corporation: Regulated Decision Support FrameworkÌý
01 March 2024
Clinical Management Support Software
MHRA reference: ÌýÌýÌý
Globus Medical: ExcelsiusGPSÌý
06 March 2024
Robot, surgical, navigation unitÌý
Model: 6143.2844ÌýÌý
MHRA reference: Ìý
Legency Remedies Private Limited: Sodium Chloride Irrigation Solution 0.9% w/v Sodium Chloride Eye Wash Solution 0.9% w/v Sodium Chloride Inhalation Solution 0.9 % w/v
04 March 2024
ÌýÌýÌýÌý
NuVasive: MAGEC SystemÌý
March 2024
MHRA reference: ÌýÌýÌýÌý
QIAGEN: EZ2 Connect MDxÌý
February 2024
An electrically-powered instrument
MHRA reference: ÌýÌýÌýÌý
Symbios: ORIGIN
04 March 2024
MHRA reference: