BD Vacutainer Urine Collection Tubes Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of diagnostic medical devices. The source text states no illnesses or injuries have been reported, and the hazard—potential loss of preservative effectiveness due to temperature exposure—is theoretical. Per the severity rubric, recalls with theoretical hazards and no reported injuries fall into the High category as risk-of-harm products.
Plain-English summary
BD Vacutainer urine collection tubes and related kits are being recalled due to facility temperature excursions that occurred from June through August 2021, prior to shipment. The affected products include the BD Vacutainer C&S Preservative Urine Tube (Model 364951), BD Vacutainer C&S Transfer Straw Kit (Model 364953), and BD Vacutainer Collection Kit (Model 364957), manufactured by Mckesson Medical-Surgical.
Exposure to higher temperatures may have impacted the effectiveness of the preservative in these collection tubes. The preservative is essential for maintaining specimen integrity during culture and sensitivity testing. All lots received between June 1, 2021 and September 30, 2021 are affected. Products were distributed nationwide in the United States.
Healthcare facilities and patients should verify the lot number of urine collection tubes in their possession. If affected lots were used to collect specimens, recollection may be necessary. Inquiries regarding affected lots should be directed to the product supplier or distributor.
The recalled product
- Product
- a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICK
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- loss-of-effectiveness
- specimen-integrity
- temperature-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- GTIN: a. 00382903649518 EA
- 30382903649519 PK
- 50382903649513. b. 00382903649532
- 30382903649533
- 50382903649537. c. 00382903649570 EA
- 50382903649575 CS
Distribution
Distributed nationwide across the United States.
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