Reported Aug 30, 2017 · Terminated
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY…
Custom Assemblies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Custom Assemblies Inc · 330 E. Main Street · Pine Level, NC · 27568
Is this the product you have?
- Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot Numbers: 42696-1602, 43200-1604, 433322-1605 (c) 2 Lot Numbers: 43056-1604, (d) 3 Lot Numbers: 42836-1603, 43182-1604 (e) 4 Lot Numbers: 42794-1603 (f) 5 Lot Numbers: 42912-1603 (g) 6 Lot Numbers: 43416-1606 (h) 7 Lot Numbers: 43414-1606 - Amount recalled
- 2155 kits
Where it was sold
Why it was recalled
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
This product could cause temporary or reversible health problems — stop using it.
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