FDA Medical Device Recalls (openFDA)
Allegiance Healthcare Corp.: Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
- Recall number
- Z-0576-03
- Recalling firm
- Allegiance Healthcare Corp.
- Product
- Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
- Status
- Terminated
- Initiated
- 2003-01-22
- Posted
- 2003-02-25
- Terminated
- 2003-12-03
- Reason
- The product labeled as sterile had not been through its sterilzation cycle.
- Root cause
- Other
- 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.
- Quantity
- 320 drapes
- Distribution
- New Jersey, Georgia, Washington and Florida
- Lot, serial or model codes
- lot number 02LFRW95
- 510(k) numbers
- ["K002419"]
- PMA numbers
- not on file
- Product code
- KKX--
- Firm FEI
- 3001236905
- Firm city
- Mcgaw Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28