C P Medical Inc. Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}). Produc Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}). Produc
Brand
C P Medical Inc.
Lot Codes / Batch Numbers
M397, M398 (Butler code 029254)
Products Sold
M397, M398 (Butler code 029254)
C P Medical Inc. is recalling Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed due to The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
Recommended Action
Per FDA guidance
CP Medical, Inc. sent a "RECALL NOTICE" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026