See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products Inc · 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 n…
Open FDA's page for this record- Cfres ID
- 218833
- Product res number
- Z-1774-2026
- Event date initiated
- 2026-02-17
- Event date posted
- 2026-04-06
- Recall status
- Open, Classified
- Res event number
- 98469
- Product code
- FPA
- Product description
- See Luer Cap Set, MPC-130, set, administration, intravascular
- Code info
- UDI +B144MPC1300/$$529105203895, Lot Number 20389
- Firm FEI number
- 1000138417
- Recalling firm
- Molded Products Inc
- Address 1
- 1812 Industrial Pkwy
- City
- Harlan
- State
- IA
- Postal code
- 51537-2401
- Additional info contact
- Teresa Wooster 712-755-5557 Ext. 236
- Root cause description
- Process control
- Product quantity
- 26900 units
- Distribution pattern
- US Nationwide distribution in the states of TN, TX, NV, IL, FL.
- 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.
- Action
Molded 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.
- K numbers
- K925927
- Harmonized identifiers (openFDA)
- Device name
- Set, Administration, Intravascular
- Medical specialty description
- General Hospital
- Regulation number
- 880.5440
- Device class
- 2
- K number
- K142011, K832549, K950970, K942446, K771362, K992266, K913311, K020544, K933852, K944619, K900651, K970800, K962801, K952664, K860609, K934513, K031783, K101958, K940689, K011928, K871843, K092527, K801821, K921391, K021999, K923560, K003225, K013502, K011858, K810721, K041042, K940832, K013104, K213846, K885264, K103551, K931550, K821995, K910159, K050600 +1,135 more
- Registration number
- 1220973, 3012552122, 3047799708, 3006082230, 3005340341, 2016945, 3016798778, 3010882065, 3014383500, 2649614, 9617604, 1911916, 3014498869, 1625425, 1643817, 3009742443, 3002807090, 3010273872, 9680794, 1038185, 3009631669, 3010413216, 3020460367, 3005609751, 3006846316, 3010293992, 8010026, 3027327302, 9612152, 2520313, 1643059, 3012798826, 3012809732, 3008692839, 3004215921, 1047843, 3000268902, 3011270181, 9616567, 9610993 +391 more
- FEI number
- 1220973, 3001639729, 3012552122, 3047799708, 3006082230, 3005340341, 2016945, 3016798778, 3014383500, 3001451226, 2649614, 3000327333, 1911916, 3014498869, 1625425, 1643817, 3009742443, 1000518731, 3010273872, 1038185, 3009631669, 3010413216, 3003528016, 3020460367, 3005609751, 3006846316, 3010293992, 3027327302, 2520313, 1643059, 3012798826, 3012809732, 3008692839, 3004215921, 1047843, 3000268902, 3011270181, 3004140833, 3006194679, 3015309643 +391 more