FDA Medical Device Recalls (openFDA)
ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
- Recall number
- Z-0565-2026
- Recalling firm
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Product
- SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
- Status
- Open, Classified
- Initiated
- 2025-09-26
- Posted
- 2025-11-19
- Terminated
- not on file
- Reason
- Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Root cause
- Process change control
- Action
- On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls. Customers are instructed to: a) Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) If critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results). d) Dispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com. For questions or assistance - contact FieldActions@aspglobal.com (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET
- Quantity
- 16920
- Distribution
- Distribution US nationwide and Canada.
- Lot, serial or model codes
- Model Number: 07 9502 GTIN (Inner Pack): 30643351000353 UDI-DI: 10643351000359 All Lots produced from 01JUN2022 to 28FEB2025: 21G4272, 22F4084, 22F4109, 23A4170, 23H4154, 23H4228, 23I4057, 23I4058
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GIO
- Firm FEI
- 3004824601
- Firm city
- Austell
- Firm state
- GA
- 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