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Terminated

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

FDA Recall Z-1250-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeFDE
Date Initiated2022-05-03
Date Terminated2024-05-31
Product Quantity125 units

Reason for Recall

Potential for the tip of the electrode to detach during use.

Firm Action

The firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952204CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADESConmedcorp · 1995-05-25

Official Source

View FDA Recall →

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

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