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    Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap 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) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes: '3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under three private labels, Webster Veterinary, Butler, and Phoenix Pharmaceutical, Inc. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only Distributed by: Webster Veterinary Supply, Inc. CUTTING NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'. Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'. Phoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.

    FDA Recall
    Terminated ·C P Medical·Product code GAM·April 3, 2007

    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'.

    FDA Recall
    Terminated ·C P Medical·Product code GAW·April 3, 2007

    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 3/0 (2.0 Metric), NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid). Product is labeled in part: "***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.

    FDA Recall
    Terminated ·C P Medical Inc.·Product code GAM·January 2, 2009

    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}). Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.

    FDA Recall
    Terminated ·C P Medical Inc.·Product code NEW·January 2, 2009

    Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle

    FDA Recall
    Terminated ·C P Medical Inc.·Product code NEW·April 23, 2014

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025