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Terminated

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

FDA Recall Z-1255-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeLRO
Date Initiated2022-05-03
Date Terminated2022-06-27
Product Quantity24 kits

Reason for Recall

Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.

Firm Action

ROI notified the sole consignee with a MEDICAL DEVICE RECALL NOTICE by email on 05/03/2022. The letter explained the problem and requested the following actions: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the item/lot number listed in the above table are in your inventory. 2. HOLD: Quarantine all affected kits in your inventory and do not further distribute or use. 3. REPLY: Complete the recall reply form attached to this notice and return to [email protected]. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. 4. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this recall notice. You may include a copy of this notice as well as the notice issued by Medline to supplement your communication.

Root Cause

Other

Distribution Pattern

FL

Official Source

View FDA Recall →

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

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