Facility
KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill
9 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3007697999 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer); Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Nicolas Ayllon Ave. No. 8400 Ate-Vitarte Lima Lima (Region), PE 12 |
| Registration status | Active · expires 2026 |
| Parent company | KIMBERLY-CLARK CORPORATION (owner-operator 10028842) |
| Brand names | Plenitud |
Devices registered here (1)
- Garment, Protective, For IncontinenceProduct code EYQ · Class I · Gastroenterology, Urology · 21 CFR 876.5920
Recalls & enforcement
- Class IITerminated2013-10-29Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
- Class IITerminated2013-10-24Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.
- Class IITerminated2013-03-06Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
- Class IITerminated2012-07-05Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
- Class IITerminated2012-04-27A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.
- Class IIITerminated2010-12-31The impacted product was not intended for commercial distribution to end users.
- Class IITerminated2010-09-16Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
- Class IITerminated2010-06-22The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
- Class IITerminated2009-09-17Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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