FDA Medical Device Recalls (openFDA)
C P Medical Inc.: Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
- Recall number
- Z-3177-2011
- Recalling firm
- C P Medical Inc.
- Product
- Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
- Status
- Terminated
- Initiated
- 2011-06-29
- Posted
- 2011-09-09
- Terminated
- 2012-05-24
- Reason
- Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
- Root cause
- Process control
- Action
- CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return. Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.
- Quantity
- 776 dozens boxes
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
- Lot, serial or model codes
- LOT Numbers: 070205-04, 070205-05, 070221-05, 070322-04, 070410-02, 070430-08, 070517-12, 070702-03, 070726-06, 070824-04, 070924-08, 071024-05, 080103-24, 080111-02, 080211-01, 080227-09, 080424-21, 080424-22, 080424-24, 080602-18, 080825-11, 080911-05, 081002-12, 081202-02, 090211-07, 090310-14, 090415-03, 090429-07, 090515-04, 090706-10, 090803-06, 090904-02, 091110-15, 091119-07, 100114-39, 100122-05, 100305-05, 100317-11, 100505-18, 100702-05, 100706-01, 100810-08, 100921-10, 101129-19, 101208-01, B0605230, D0510140, D0610330, D0611040, G0220310, G0619440, G0619530-1, H0523640, H0622330, J0528740, J0627630-1, J0628240, L0534830, and L0635430-1.
- 510(k) numbers
- ["K001173"]
- PMA numbers
- not on file
- Product code
- GAR
- Firm FEI
- 3002609049
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28