SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product D
Summary
The FDA issued a Class II for SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter by ASP Global, LLC. dba Anatomy Supply Partners, LLC.. Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes..
Details
Source
Device Recall
External ID
Z-0564-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Lot/Code Info: Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189
Quantity Affected: 620502
Reason for Recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distribution
Distribution US nationwide and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-26
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ASP Global, LLC. dba Anatomy Supply Partners, LLC. has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ASP Global, LLC. dba Anatomy Supply Partners, LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASP Global, LLC. dba Anatomy Supply Partners, LLC. have FDA actions?
ASP Global, LLC. dba Anatomy Supply Partners, LLC. has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0564-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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