Norcross, GA, United States
CP Medical Inc recalls
2 recalls recorded since 2018, most recently on 18 October 2019. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 October 2019
- Reason
- Failed to meet USP minimum average value for knot pull (tensile) strength.
- Distribution
- USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0655-2020
- Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Ongoing Class II Medical devices
- Recall started
- 4 February 2019
- Reason
- Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
- Distribution
- Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1027-2019
- Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.