The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0939-2020·Announced 2020-02-12

B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

B. Braun Medical is recalling 9,000 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.

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 3/5 (High).

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

B. Braun Medical, Inc. is recalling 9,000 units of Y-Type Blood Sets, Catalog Number 490530. The recall is due to a potential for leakage at the joint between the blood filters and tubing.

The affected products were distributed nationwide in the United States. The recall includes specific lot numbers with expiration dates ranging from April 30, 2022, to June 30, 2022.

Healthcare facilities and consumers should stop using the affected blood sets and contact B. Braun Medical for further instructions or a replacement.

The recalled product

Product
Y-Type Blood Set, Catalog Number 490530
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Blood Administration
Hazard
Affected units
9,000

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)

  • GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30
  • 2022
  • 61677192 - Expiration Date: April 30
  • 61678186 - Expiration Date: April 30
  • 61681736 - Expiration Date: May 31
  • 61685105 - Expiration Date: June 30

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by B. Braun Medical, Inc. 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 7 products in this recall →

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