Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect
Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.
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: This recall involves a manufacturing defect in a medical device component affecting the fluid pathway of pressure monitoring systems. While no illnesses or injuries have been reported, the defect represents a risk of harm to the proper function of cardiac monitoring equipment, meeting the criteria for High severity per the rubric.
Plain-English summary
Medline Industries is recalling pressure monitoring line (PML) convenience kits manufactured with a defect in the female luer fittings. The fittings were produced with excess material near the fluid pathway. Approximately 1,669 units were distributed worldwide, including in the United States, Netherlands, New Zealand, and Slovakia. The affected products are identified by specific reference numbers and lot numbers provided in the FDA recall notice.
The recalled product
- Product
- namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,669
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)
- 1) REF60010468
- UDI/DI 10193489040319 (each) 20193489040316 (case)
- Lot Number 0000140099
- 2) REF60010511
- UDI/DI 10193489040357 (each) 20193489040354 (case)
- Lot Number 0000141267
- 3) REF60020323
- UDI/DI 10193489041071 (each) 20193489041078 (case)
- Lot Number 0000139976
- 4) REF60020676
- UDI/DI 10193489041200 (each) 20193489041207 (case)
- Lot Number 0000140410
- 5) REF60035977
- UDI/DI 10193489042672 (each) 20193489042679 (case)
- Lot Number 0000140081
- 6) REF60040273
- UDI/DI 10193489042832 (each) 20193489042839 (case)
- Lot Number 0000140896
- 7) REF60100313
- UDI/DI 10193489045048 (each) 20193489045045 (case)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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