Medline tracheostomy and tonsil kits contain catheters failing specifications
Medline procedure kits including adult tracheostomy tube insertion, T&A and ear packs are being recalled because sample catheters did not meet performance specifications. 217,390 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 Adult Tracheostomy Tube Insert, ASC T&A, Conway T&A Sinus and Ear Pack, among the products listed in the recall documents. The action covers 217,390 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: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
- Manufacturer
- Medline Industries, LP
- Affected units
- 217,390
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 MNS12180: UDI/DI 10653160327134 (each)
- 40653160327135 (case)
- Lot Number 22FBM309
- Lot Number 22DBJ094
- Lot Number 22OBH091
- Lot Number 21HBC428
- Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each)
- 40195327207084 (case)
- Lot Number 24ABC426
- Lot Number 23JBM836
- Lot Number 23HBS357
- Lot Number 22KBS784
- Lot Number 22IBV574
- Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each)
- 40195327689101 (case)
- Lot Number 26ABH211
- Lot Number 25GBS702
- Lot Number 25EBT418
- Lot Number 24LBP073
- Lot Number 24JBI868
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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