C P Medical: Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under two private labels, Webster Veterinary and Butler. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'. Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.

Recall number

Z-0808-2007

Recalling firm

C P Medical

Product

Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under two private labels, Webster Veterinary and Butler. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'. Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.

Status

Terminated

Initiated

2007-04-03

Posted

2007-05-24

Terminated

2008-08-01

Reason

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

Root cause

Other

Action

On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.

Quantity

1332 suture packets

Distribution

Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa. Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution. Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.

Lot, serial or model codes

CP Medical Product label is coded 8665P. Lot number J0629930-1 expiration 2011-09.  Private distributed label for Webster Veterinary is coded 07-836-4643(8665P). Lot number J0629930-1 expiration 2011-09.  Private distributed label for Butler is coded 032002. Lot number J0629930-1 expiration 2011-09.

510(k) numbers

["K001185"]

PMA numbers

not on file

Product code

GAW

Firm FEI

3002609049

Firm city

Portland

Firm state

OR

Firm country

not on file

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

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