Recalls / —
—#42684
Product
Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. PO23AAMCC - Arthroscopy Kit b) Cat. PO23TKMCC - Total Knee Kit c) Cat. SOP11OPFGB - Ortho Pack d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk
- FDA product code
- LRO — General Surgery Tray
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Cat. PO23AAMCC, order numbers 641370 and 655171; Cat. PO23TKMCC, order numbers 637245 and 639306; Cat. SOP11OPFGB, order numbers 640349, 641634, 644009, 651563 and 653696; Cat. SCV48CVJHD, order numbers 722851 and 728463.
Why it was recalled
The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
Root cause (FDA determination)
Other
Action the firm took
Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health for replacement.
Recalling firm
- Firm
- Cardinal Health
- Address
- 1430 Waukegan Rd, McGaw Park, Illinois 60085
Distribution
- Distribution pattern
- South Carolina, New York, Nebraska, Florida and internationally to Canada
Timeline
- Recall initiated
- 2005-10-03
- Posted by FDA
- 2005-11-18
- Terminated
- 2006-12-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #42684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.