Various custom surgical kits manufactured for CMS recall: Particulate Matter
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety…
Why was Various custom surgical kits manufactured for CMS 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(a) Lot Numbers: 42754-1603, 42798-1603, 43030-1604 (b) Lot Numbers: 42696-1602, 43200-1604, 433322-1605 (c) Lot Numbers: 43056-1604, (d) Lot Numbers: 42836-1603, 43182-1604 (e) Lot Numbers: 42794-1603 (f) Lot Numbers: 42912-1603 (g) Lot Numbers: 43416-1606 (h) Lot Numbers: 43414-1606
- Product
- Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety…
- Recalling firm
- Custom Assemblies Inc
- Quantity
- 2155 kits
- Distribution
- Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
- Recall date
- August 30, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)