FDA Medical Device Recalls (openFDA)
Hollister Stier Laboratories LLC: 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
- Recall number
- Z-0871-06
- Recalling firm
- Hollister Stier Laboratories LLC
- 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
- Status
- Terminated
- Initiated
- 2006-04-20
- Posted
- 2006-05-17
- Terminated
- 2007-03-03
- Reason
- Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.
- Root cause
- Other
- 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
- 87,900 vials
- Distribution
- Vials were distributed to clinics, pharmacies and physicians nationwide.
- Lot, serial or model codes
- Lot #6743 Item #s 7515ZA, 7515ZC, 7515ZD
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LDH
- Firm FEI
- 3010477
- Firm city
- Spokane
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28