Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case

FDA Recall Z-0576-03 · Posted 2003-02-25

Recalling FirmAllegiance Healthcare Corp.
Recall StatusTerminated
Product CodeKKX
Date Initiated2003-01-22
Date Terminated2003-12-03
Product Quantity320 drapes

Reason for Recall

The product labeled as sterile had not been through its sterilzation cycle.

Firm Action

Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers.

Root Cause

Other

Distribution Pattern

New Jersey, Georgia, Washington and Florida

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002419SURGICAL DRAPESAllegiance Healthcare Coporation · 2000-08-15

Official Source

View FDA Recall →

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

↑