Recall Z-1234-2017— Custom Medical Specialties, Inc.
Class II · Ongoing
Class II FDA medical device recall by Custom Medical Specialties, Inc., initiated 2016-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.. Reason: Sterility of syringe product could not be assured..
- Recalling firm
- Custom Medical Specialties, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2016-09-20
- Firm location
- Pine Level, NC, United States
Product description
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Reason for recall
Sterility of syringe product could not be assured.
Data sourced from openFDA. This site is unofficial and independent of the FDA.