Medline CRANI procedure kits contain catheters failing performance specifications
Medline CRANI procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 3,521 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 CRANI, covering SKUs DYNJ908097, DYNJ908097A and DYNJ908097B, among the products listed in the recall notice. The action covers 3,521 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) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU…
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,521
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 DYNJ908097: UDI/DI 10193489973846 (each)
- 40193489973847 (case)
- Lot Number 23FBQ975
- Lot Number 23FBF166
- Lot Number 23DBM780
- Lot Number 22KBM832
- Lot Number 22JBY524
- Lot Number 22GBR089
- Lot Number 22FBR153
- Lot Number 22FBC633
- Lot Number 22EBB478
- Lot Number 22BBX706
- Lot Number 22BBU902
- Lot Number 22ABN864
- Lot Number 21IBO640
- SKU DYNJ908097A: UDI/DI 10195327507077 (each)
- 40195327507078 (case)
- Lot Number 24EBC216
- Lot Number 24CBU878
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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