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Terminated

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

FDA Recall Z-0837-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeLRS
Date Initiated2022-02-24
Date Terminated2022-04-25
Product Quantity1750 kits

Reason for Recall

Recalled devices were packaged in convenience kits.

Firm Action

A customer letter dated February 24, 2022 was issued to the impacted consignee. The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers. A reply form should be completed and returned to ROi confirming receipt and understanding of the notification. End users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.

Root Cause

Material/Component Contamination

Distribution Pattern

US Nationwide distribution in the state of Missouri.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEBecton Dickinson Vacutainer Systems · 1999-05-28

Official Source

View FDA Recall →

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

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