Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage
Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.
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. The hazard involves compromised sterility of a medical device used in surgical procedures, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is initiating an Urgent Medical Device Customer Notification for certain Intersept Custom Tubing Packs. The recall involves 1,552 units of the product, which is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures.
The recall was initiated because Medtronic confirmed that the packaging trays for these specific tubing packs are susceptible to damage. This damage can compromise the sterility of the product. The affected units were distributed worldwide, including nationwide in the United States and in Canada and Malaysia.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the use of these products. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2…
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Category
- Medical Device — Surgical Tubing
- Affected units
- 1,552
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)
- Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666
- 1A30R6- 12132577 12219267
- 2493R24- 11187015 11199707 11224309 11227205 11556735
- 12411746 7E64R2- 11933798
- 7J53R2- 12172725
- 7M13R1- 12168157
- 7M14R1- 12349772
- 7N16R- 12349786
- 7P25R1- 12327801 12449801 12457250
- 7P93R1- 12349795 12374420
- 7Q11R1- 12344028 12456303
- BB7L63R2- 12408737
- BB7N26R- 12312571
- CB5175R13- 11292866 11334859 11432873 11442937 12182778 12411655
- CB5Q03R6- 11713162 11766245 11787583 11923139 11934952
- CB5Q03R7- 12114626
- CB6C53R6- 12423767
- CB7C15R2- 12411647
- CB7C59R2- 11731501
- CB7C74R2- 11895167
Distribution
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