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Open, Classified

Remington MEDICAL Drainage Bag, REF 600-D;

FDA Recall Z-0487-2024 · Posted 2023-12-05

Recall StatusOpen, Classified
Product CodeEXF
Date Initiated2023-11-03
Product Quantity3080 devices

Reason for Recall

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

Firm Action

Remington Medical issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 11/03/2023 via email. The notice explained the issue, the potential risk, and requested the notice be communicated to all parties to whom it was distributed. If allowed by the consignee's internal procedures, remove the pouches from the box, as the pouch label correctly identifies the actual Date of Manufacture date and Use By date. The firm will replace the affected devices.

Root Cause

Labeling mix-ups

Distribution Pattern

US: PA and FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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