Recall Z-2582-2010 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
C P Medical
Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". Intended for use in general soft tissue approximation and/or ligation including use in pediatr
| Date | Sep 27, 2010 (initiated Sep 17, 2008) |
| Status | Terminated |
| Reason | Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised. |
| Root cause | Vendor change control |
| Action | On 09/17/2008, the firm's Sale Representative began using the Telephone Script and calling all their customers. On 09/19/2008, the firm began sending the Recall Notice, dated 9/17/2008, letter to their customers. The letter states that the recalled product is Polydioxanone Suture, Code M397, Lot Number L0535440, Expiration Date: November 2009. The customers are advised to discontinue selling this product and return any existing stock to CP Medical. The firm also requests their consignees to notify their sub-accounts about this recall notice if the product is further distributed. The custo |
| Quantity | 1684/12 pcs. Boxes (1628/12 pcs. Boxes to veterinary market, 56/12 pcs. Boxes to human suture market) |
| Distribution | Worldwide Distribution -- US, Australia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE Cp Medical, Nov 16, 2001 |