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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 20, 2006
Date Posted May 17, 2006
Recall Status1 Terminated 3 on March 03, 2007
Recall Number Z-0871-06
Recall Event ID 35212
Product Classification System, Delivery, Allergen And Vaccine - Product Code LDH
Product Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
Code Information Lot #6743 Item #s 7515ZA, 7515ZC, 7515ZD
Recalling Firm/
Hollister Stier Laboratories LLC
3525 N Regal St
Spokane WA 99207-5788
For Additional Information Contact Tela Engdahl
Manufacturer Reason
for Recall
Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.
FDA Determined
Cause 2
Action On 4/20/06 the firm sent an overnight letter titled DEVICE RECALL to their customers. The consignees were advised of the problem and were requested return of the vials. The letter also instructs consignees that if they have any remaining product in the vials, to destroy the product.
Quantity in Commerce 87,900 vials
Distribution Vials were distributed to clinics, pharmacies and physicians nationwide.
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.