Medline cardiovascular and peripheral vascular packs contain substandard catheters
Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 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 BNT CV Pack (DYNJ912271), CV Pack Part 1 (DYNJ31204D) and Kit Peripheral Vascular MMC (DYNJ905368D), among the products listed in the recall notice. The action covers 1,248 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) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU…
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,248
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 DYNJ912271: UDI/DI 10198459688324 (each)
- 40198459688325 (case)
- Lot Number 26CBQ109
- Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each)
- 40193489957991 (case)
- Lot Number 25FBO720
- Lot Number 24KBO387
- Lot Number 24KBO015
- Lot Number 24KBD819
- Lot Number 24KBA736
- Lot Number 24FBG144
- Lot Number 24DBO838
- Lot Number 24BBC453
- Lot Number 24ABM118
- Lot Number 23KBS950
- Lot Number 23IBC670
- Lot Number 22LBN883
- Lot Number 22KBF121
- Lot Number 22IBN293
- Lot Number 22FBO695
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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