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Terminated

Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.

FDA Recall Z-2799-2015 · Posted 2015-09-21

Recalling FirmResource Optimization & Innovation Llc
Recall StatusTerminated
Product CodeLRO
Date Initiated2015-08-19
Date Terminated2017-04-05
Product Quantity67 kits

Reason for Recall

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Firm Action

On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.

Root Cause

Material/Component Contamination

Distribution Pattern

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Official Source

View FDA Recall →

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

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