Medline carotid neuro and VP shunt packs contain substandard catheters
Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units 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 medical procedure kits labeled as Carotid Neuro Pack (SKU DYNJ44926G) and VP Shunt CDS (SKUs CDS983800J and CDS983800K). The action covers 342 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) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
- Manufacturer
- Medline Industries, LP
- Affected units
- 342
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 DYNJ44926G: UDI/DI 10193489766554 (each)
- 40193489766555 (case)
- Lot Number 24EBH848
- Lot Number 24DBK995
- Lot Number 23JBP023
- Lot Number 23HBR067
- Lot Number 23FBM330
- Lot Number 23EBK061
- Lot Number 22JBG042
- Lot Number 22GBH864
- Lot Number 22DBT571
- Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each)
- 40195327684663 (case)
- Lot Number 25DMJ438
- Lot Number 25CMH178
- Lot Number 24IME720
- Lot Number 24HMG912
- Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each)
- 40198459518974 (case)
- Lot Number 26CMC503
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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