Z-3177-2011

Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and...

Name: Z-3177-2011 Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and...
Creator: C P Medical Inc.
Published: 2011-06-29
License: https://open.fda.gov/license/

C P Medical Inc. / initiated 2011-06-29 / Terminated / root cause: manufacturing process

FDA source

C P Medical Inc. began a recall of Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in... on 2011-06-29. The reason FDA records is "Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3177-2011
Status: Terminated
Initiated: 2011-06-29
Posted: 2011-09-09
Terminated: 2012-05-24
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.
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
Root cause tag: manufacturing process
FDA 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 in commerce: 776 dozens boxes
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
Product codes and lots: 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.

Product code GAR

K001173Class IINylon, Nonabsorbable Surgical Sutures UspCp Medical / cleared 2000-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)