Molded Products Luer cap sets recalled after threaded sleeve detachment complaint
Molded Products is recalling the MPC-130 See Luer Cap Set following a confirmed complaint that the threaded sleeve was not engaged and became detached. 26,900 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 of an intravascular set where a component can detach, a risk of harm with no injuries reported in the source.
Plain-English summary
Molded Products, Inc. is voluntarily recalling the See Luer Cap Set, MPC-130, an intravascular administration set. The action covers 26,900 units, UDI +B144MPC1300/$$529105203895, lot number 20389.
The recall is based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached. The FDA classified the action as Class II.
Distribution was within the United States, to Tennessee, Texas, Nevada, Illinois and Florida. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the UDI and lot number above, quarantine it, and follow the instructions issued by Molded Products.
The recalled product
- Product
- See Luer Cap Set, MPC-130, set, administration, intravascular
- Manufacturer
- Molded Products Inc
- Affected units
- 26,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI +B144MPC1300/$$529105203895
- Lot Number 20389
Distribution
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