The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1618-2022·Announced 2022-08-31

BD Vacutainer Blood Collection Tubes Recalled for Temperature-Exposure Effectiveness Loss

BD Vacutainer blood collection tubes are recalled due to potential temperature damage during storage from June to August 2021. Affected tubes received between June 1 and September 30, 2021 may have reduced effectiveness.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II precautionary recall with no reported adverse events or confirmed product failures. The temperature exposure is confirmed, but its impact on product effectiveness is theoretical and unconfirmed, consistent with the rubric category of voluntary precautionary recalls.

Plain-English summary

Becton Dickinson BD Vacutainer blood collection tubes are being recalled due to potential effectiveness loss from temperature excursions. The recall affects multiple tube models and formulations, including SST (serum separator), plain, CPT, RST, and sodium citrate variants. Model numbers include 367983, 367988, 367986, 367987, 367981, 366430, 365978, 362761, 368774, and 363083.

Between June 2021 and August 2021, tubes stored at the manufacturing facility experienced exposure to higher-than-recommended temperatures prior to shipment. All affected lots were received between June 1, 2021 and September 30, 2021. Temperature exposure may have impacted product effectiveness, though no adverse events or product failures have been reported to date.

The affected products are distributed nationwide. Blood collection tubes require consistent storage conditions to maintain proper function and ensure specimen integrity for accurate laboratory testing.

Customers with affected inventory should contact their supplier or the recalling firm for instructions on handling recalled lots. The FDA classified this as a Class II recall.

The recalled product

Product
a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD…
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Blood Collection
Hazard

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 (13)

  • GTIN: a. 00382903679836
  • 50382903679831. b. 00382903679881
  • 50382903679886. c. 00382903679867
  • 50382903679862. d. 00382903679874
  • 50382903679879
  • e. 00382903679812
  • 50382903679817. f. 00382903664306
  • 30382903664307
  • 50382903664301. g. 00382903659784
  • 50382903659789. h. 00382903627615
  • 50382903627610. i. 00382903687749
  • 50382903687744. j. 00382903630837
  • 50382903630832.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 55 products in this recall →

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