Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
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 involves a medical device used in high-risk cardiovascular procedures that is described as defective. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are cited in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 15,817 units of the Terumo Pall AL6X Arterial Blood Line Filter. These filters are indicated for use in cardiopulmonary bypass procedures to remove micro-emboli greater than 40 microns in size from the arterial line. The devices are distributed nationwide and are available either as single sterile filter units or packaged as part of a Terumo Cardiovascular Procedure Kit.
The recall was initiated because the medical device is defective. The source text does not specify the exact nature of the defect, nor does it report any specific injuries, illnesses, or deaths associated with the use of these filters.
Healthcare facilities and consumers should identify affected units by checking the Part Number AL6X and the specific lot codes listed in the official recall notice. Affected lot codes for single filters include MM19, MN23, NC15, and many others. Affected lot codes for filters packaged in Convenience Kits include PN19, QA14, QC11R, and many others. Users should stop using the recalled filters and contact Terumo Cardiovascular Systems Corporation for instructions on return or replacement.
The recalled product
- Product
- Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 15,817
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 (20)
- MN23
- NC15
- ND01
- ND08
- ND29
- NE11
- NE18
- NE25
- NF09
- NF31
- PA23
- PD05
- PE02
- PF14
- PF21
- PG04
- PG11
- PG18
- PG25
- PH09
Distribution
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