Medline retina procedure kits contain catheters failing performance specifications
Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.
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: 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 Retina LAC/USC CDS medical procedure kits, covering SKUs CDS983775I, CDS983775J and CDS983775K, among the products listed in the recall notice. The action covers 2,340 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) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377
- Manufacturer
- Medline Industries, LP
- Affected units
- 2,340
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 CDS983775I: UDI/DI 10193489980660 (each)
- 40193489980661 (case)
- Lot Number 24BBF438
- Lot Number 23LBR516
- Lot Number 23LBI385
- Lot Number 23GBW083
- Lot Number 23GBT137
- Lot Number 23GBA705
- Lot Number 23EBT206
- Lot Number 23BBN853
- Lot Number 23BBG437
- Lot Number 23BBG444
- Lot Number 23BBA852
- Lot Number 23BBA859
- Lot Number 22IBR361
- Lot Number 22IBF066
- Lot Number 22GBA053
- Lot Number 22GBA052
- Lot Number 22GBA054
- Lot Number 22DBM893
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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