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U.S. Department of Health and Human Services

Class 2 Device Recall SAFETFILL

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 Class 2 Device Recall SAFETFILLsee related information
Date Initiated by FirmSeptember 26, 2025
Date PostedNovember 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0544-2026
Recall Event ID 97592
510(K)NumberK983517 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Code Information Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003
FEI Number 3004824601
Recalling Firm/
Manufacturer		 ASP Global, LLC. dba Anatomy Supply Partners, LLC.
7800 Third Flag Pkwy
Austell GA 30168-7657
For Additional Information ContactTracy Weldon
+1-470-6490135
Manufacturer Reason
for Recall		Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
FDA Determined
Cause 2		Process change control
ActionOn 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 in Commerce78000
DistributionDistribution US nationwide and Canada.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JKA
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