The Recall Desk
HighFDA (Devices)·Z-0941-2020·Announced 2020-02-12

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

B. Braun Medical is recalling 19,500 Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

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: 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 19,500 units of the Safeline Y-Type Blood Set, Catalog Number V2500. The recall is being conducted because of 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, 2024, to June 30, 2024. The specific lot numbers involved are 61674884, 61677634, 61678262, 61680625, and 61685110.

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

The recalled product

Product
Safeline Y-Type Blood Set, Catalog Number V2500
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Blood Administration Set
Hazard
Affected units
19,500

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: 04046964188633 Lot Numbers: 61674884 - Expiration Date: April 30
  • 2024
  • 61677634 - Expiration Date: April 30
  • 61678262 - Expiration Date: May 31
  • 61680625 - Expiration Date: May 31
  • 61685110 - 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 →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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