Ethicon, Inc.: VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G

Is my product affected?

VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G

• UPC 10705031051324

Check against the official notice below — it lists the full affected range.

What happened

Ethicon, Inc. has recalled VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 sutures intended for eye surgery because the suture inside the foil package may not match what is labeled on the package and carton. The correct product should be size 10-0, 4 inches long, monofilament construction with a single needle. However, some packages may contain an incorrect suture that is size 6-0, 18 inches long, with braided construction and two needles instead. This recall affects 1,032 units with Lot/Serial No. PJ5352 and expiration date 07/31/2024 that were distributed internationally to Australia, Canada, Japan, and New Zealand.

The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles

Details from the source

Reason for recall: Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles Distribution: International distribution including the countries of Australia, Canada, Japan, and New Zealand Quantity: 1,032 eaches (OUS only) Lot/code info: Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Neoprobe GDS Control Unit, Model Number NPCU32020-09-07
• Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.2020-09-14
• (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item2020-09-03
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).2020-09-15
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).2020-09-15

All FDA (Device enforcement) recalls