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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Empty Vial (SEV)

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  Class 2 Device Recall Sterile Empty Vial (SEV) see related information
Date Initiated by Firm February 03, 2015
Date Posted September 12, 2016
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-2785-2016
Recall Event ID 74851
Product Classification System, delivery, allergen and vaccine - Product Code LDH
Product GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Code Information SEV2120414, SEV2120514
Recalling Firm/
Manufacturer		 Allergy Laboratories, Inc.
1005 SW 2nd St
Oklahoma City OK 73109-1006
For Additional Information Contact
405-235-1451
Manufacturer Reason
for Recall		 Potential for glass particles within the vials
FDA Determined
Cause 2		 Process control
Action Allergy Laboratories notified the sole consignee via phone call on February 3, 2015. For further information, please call (405) 235-1451.
Quantity in Commerce 81,625 vials (3,265 packs)
Distribution US Distribution to the state of : NC
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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