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Terminated

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

FDA Recall Z-1942-2020 · Posted None

Recalling FirmKarl Storz Endoscopy
Recall StatusTerminated
Product CodeNKC
Date Initiated2019-01-09
Date Terminated2022-09-28
Product Quantity543 boxes were distributed; 10 ea per box.

Reason for Recall

The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

Firm Action

The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm.

Root Cause

Vendor change control

Distribution Pattern

57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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