Medline gynaecology laparoscopy packs contain catheters failing performance specifications
Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 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 Basic GYN, CW Lap GYN, D&C Hysteroscopy, Deaconess Pelvic Lap Pack, Floyd Lap GYN, GYN Lap Pack, GYN Laparoscopy and GYN Minor Pack, among the products listed in the recall documents. The action covers 44,656 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 BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
- Manufacturer
- Medline Industries, LP
- Affected units
- 44,656
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 DYNJ905924B: UDI/DI 10193489773484 (each)
- 40193489773485 (case)
- Lot Number 24GMJ742
- Lot Number 24FMC978
- Lot Number 24CMA556
- Lot Number 24BMI027
- Lot Number 24AMF247
- Lot Number 24AMA807
- Lot Number 23IMF051
- Lot Number 23HMG141
- Lot Number 23EMF259
- Lot Number 23DMA689
- Lot Number 23CMF097
- Lot Number 23CMC699
- Lot Number 22LME333
- Lot Number 22KMB390
- Lot Number 22HMC449
- Lot Number 22GMD678
- Lot Number 22FMG214
- Lot Number 22DME100
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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