Medline open heart and cardiac kits contain catheters failing specifications
Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are 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 CH Open Heart, Adult Cardiac Kit, AHT CVOR CABG and APH Emergency Open Heart Pack, among the products listed in the recall documents. The action covers 168,968 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 CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
- Manufacturer
- Medline Industries, LP
- Affected units
- 168,968
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 CDS983773G: UDI/DI 10193489344240 (each)
- 40193489344241 (case)
- Lot Number 21ABD933
- Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each)
- 40193489847124 (case)
- Lot Number 22IBJ338
- Lot Number 22EBL456
- Lot Number 22EBL231
- Lot Number 22BBW955
- Lot Number 22ABC123
- Lot Number 21IBM442
- Lot Number 21IBI539
- Lot Number 21FBT730
- Lot Number 21EBA066
- Lot Number 21CBW872
- Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each)
- 40195327233618 (case)
- Lot Number 23HBV936
- Lot Number 23HBL135
- Lot Number 23HBH924
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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