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Recall Observatory FDA recall evidence

Device product

Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175

Z-1848-2020

October 24, 2019

Class I

Product summary

Firm
Applied Medical Resources Corp
Event
Event 85057
Status
Terminated
Classification
Class I
Quantity
28,799 catheters in total
Official record key
device-enforcement:Z-1848-2020

Official wording

Reason: 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.

Code information: Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, 1339555

Distribution pattern: Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.