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U.S. Department of Health and Human Services

Class 2 Device Recall See Luer Cap Set

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 Class 2 Device Recall See Luer Cap Setsee related information
Date Initiated by FirmFebruary 17, 2026
Date PostedApril 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1774-2026
Recall Event ID 98469
510(K)NumberK925927 
Product Classification Set, administration, intravascular - Product Code FPA
ProductSee Luer Cap Set, MPC-130, set, administration, intravascular
Code Information UDI +B144MPC1300/$$529105203895, Lot Number 20389
FEI Number 1000138417
Recalling Firm/
Manufacturer		 Molded Products Inc
1812 Industrial Pkwy
Harlan IA 51537-2401
For Additional Information ContactTeresa Wooster
712-755-5557 Ext. 236
Manufacturer Reason
for Recall		Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
FDA Determined
Cause 2		Process control
ActionMolded Products, Inc. issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 02/17/2026 via USPS First Class Mail. The notice explained the issue and requested the following: Please take the following actions: 1. Please inspect your inventory to determine if you have any of the affected lot. Quarantine the affected product and initiate a return to Molded Products, Inc. for credit. 2. Share this recall notification will all users of the product to ensure they are also aware of this recall. 3. Complete the attached Medical Device Recall Customer Response Form and return to the contact noted below whether or not you have any of the impacted material so that Molded Products may acknowledge your receipt of this notification and process your return and credit. For complaints, adverse events, or questions, contact Teresa Wooster, twooster@moldedproducts.com; Ph# 800-435-8957 ext. 236 Monday Friday 8:00am-4:30pm (CT), Fax# 800-227-7935.
Quantity in Commerce26900 units
DistributionUS Nationwide distribution in the states of TN, TX, NV, IL, FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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