Medline pelvic laparoscopy packs contain catheters failing performance specifications
Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 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 the Pelvic Lap Pack, kit number/SKU DYNJ53820B. The action covers 20 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.
Affected product is UDI/DI 10195327548261 for the each and 40195327548262 for the case, spanning lot numbers including 25LBI062, 25HBR967 and 24JBK618. Distribution was worldwide, including nationwide in the United States.
Facilities should identify affected stock using the kit number, 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: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
- Manufacturer
- Medline Industries, LP
- Affected units
- 20
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 (5)
- UDI/DI 10195327548261 (each)
- 40195327548262 (case). Lot Numbers: 25LBI062
- 25HBR967
- 24JBK618
- 24BBQ860.
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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