Medline Robinson 22 Fr catheter packs fail performance specifications
Medline CATH 22F Robinson sterile 5-packs are being recalled because representative samples did not meet applicable catheter performance specifications. 1,000 units are affected.
What this means for you
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 CATH 22F Robinson STRL 5'S PK, kit number/SKU DYNJ0040839. The action covers 1,000 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 10889942046126 for the each and 40889942046127 for the case, spanning the lot numbers listed in the recall notice including 25JMK709, 25FMJ661 and 25CMG042. 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: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,000
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 (10)
- UDI/DI 10889942046126 (each)
- 40889942046127 (case)
- Lot Numbers: 25JMK709
- 25FMJ661
- 25CMG042
- 24IME549
- 24GMD004
- 24CMF091
- 24CME465
- 24BMH490.
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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