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PILLING

TELEFLEX INCORPORATED · Model IPN002645 · UDI-DI 34026704598886

FSM Prescription
10
510(k) clearances
2,231
Adverse events (2 deaths)
36
Recalls
874
Facilities

Description

TRAY SS WITH LID 32" x 7" x7"

Recalls

DateFirmReason
2025-07-18Encore Medical, LPTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
2024-06-11Medical Action Industries, Inc. 306The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile
2023-02-23Aesculap Implant Systems LLCMislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2021-11-24Howmedica Osteonics Corp.Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N:
2019-06-10Zimmer Biomet, Inc.Lack of an adequate sterilization validation.
2019-06-10Zimmer Biomet, Inc.Lack of an adequate sterilization validation.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.