Recall Z-0069-2018— Windstone Medical Packaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2017-10-24, terminated 2018-07-02. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.. Reason: Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-24
- Terminated
- 2018-07-02
- Firm location
- Billings, MT, United States
Product description
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Reason for recall
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Data sourced from openFDA. This site is unofficial and independent of the FDA.