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

Recall Z-2164-2021 — Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); A

U.S. FDA — Device Enforcement · Germany · 2021-04-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2164-2021
Date of alert: 2021-04-21
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Product category: device
Product type: Devices

Reported risk: Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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