Agency classClass IIOur severity:High FDA (Devices)·Z-1874-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.

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: This is an FDA Class II medical device recall involving a sterile, prescription perfusion system with manufacturing defects (incomplete welds). Although no illnesses or injuries have been reported, it involves a risk-of-harm product used in critical medical procedures.

Plain-English summary

Medtronic Perfusion Systems is recalling the BB11J14R2 Bridge Custom Perfusion System tubing packs. The product is a sterile, prescription medical device used in perfusion support during cardiac procedures.

Specific lots were manufactured with insufficient or incomplete welds. The company initiated the recall because these manufacturing defects may affect the product's integrity.

The recall affects 15 tubing packs with lot numbers 22128923 (expiration date 2022-10-31) and 221815851 (expiration date 2023-01-18). These packs were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

Healthcare providers should review their inventory for the recalled lot numbers and contact Medtronic Perfusion Systems for additional information or replacement product.

The recalled product

Product: Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Perfusion System
Hazard: incomplete-welds
Affected units: 15

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 (5)

GTIN 20763000446516
Lot numbers 22128923
Use By 2022-10-31
and Lot 221815851
Use By 2023-01-18

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 25 recalled by Medtronic Perfusion Systems 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 25 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · incomplete welds