Recall Z-2138-2011 ยท DTH Suture, Cardiovascular
Surgical Specialties Corp
SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
| Date | May 4, 2011 (initiated Mar 30, 2011) |
| Status | Terminated |
| Reason | Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture. |
| Root cause | Mixed-up of materials/components |
| Action | Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received |
| Quantity | 2,628 |
| Distribution | Class 3 Recall - Worldwide Distribution-- USA and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE Look, Inc., Oct 25, 1990 |