Medline cardiac surgery and ECMO packs contain substandard catheters
Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.
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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits labeled as Basic Heart Pack (DYNJ67331B), Cardiac Surgery (DYNJ911589A), Carotid Endarterectomy (DYNJ36211D) and CHLA ECMO / Cardiac Pack, among the products listed in the recall notice. The action covers 4,801 units.
During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO…
- Manufacturer
- Medline Industries, LP
- Affected units
- 4,801
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)
- Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each)
- 40195327013838 (case)
- Lot Number 23JBM539
- Lot Number 23IBF088
- Lot Number 23FBM203
- Lot Number 22JBK233
- Lot Number 22JBB115
- Lot Number 22IBO304
- Lot Number 22HBR331
- Lot Number 22FBM460
- Lot Number 22DBS093
- Lot Number 22CBJ072
- Lot Number 22BBX288
- Lot Number 21LBU240
- Lot Number 21JBP452
- Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each)
- 40198459646103 (case)
- Lot Number 26CBD487
- Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each)
- 40889942885658 (case)
Distribution
Part of a larger recall action
This product is one of 30 recalled by Medline Industries, LP 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.
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