Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1846-2020 — Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483

U.S. FDA — Device Enforcement · United States · 2019-10-24 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1846-2020
Date of alert
2019-10-24
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Applied Medical Resources Corp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00607915113407
Reported risk: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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