Recall Z-0021-2009 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 The product is used for Soft Tissue approximation.
| Date | Oct 2, 2008 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product. |
| Root cause | Packaging |
| Action | Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided t |
| Quantity | 6912 |
| Distribution | Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia. |
| FDA record | Open on fda.gov |