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U.S. Department of Health and Human Services

Class 2 Device Recall Various custom surgical kits

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  Class 2 Device Recall Various custom surgical kits see related information
Date Initiated by Firm June 15, 2017
Date Posted August 22, 2017
Recall Status1 Terminated 3 on August 28, 2017
Recall Number Z-3059-2017
Recall Event ID 77962
Product Classification General surgery tray - Product Code LRO
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 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
Code Information (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 
Recalling Firm/
Manufacturer		 Custom Assemblies Inc
330 E. Main Street
Pine Level NC 27568
For Additional Information Contact Diane McAlinn
919-202-8462 Ext. 205
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected consignees. Consignees were instructed to examine their inventory and quarantine any affected product. Consignees with questions should call 201-847-4267. For questions regarding this recall call 919-202-8462.
Quantity in Commerce 2155 kits
Distribution Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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