FDA Device

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.

Hazard

Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.

What You Should Do

Remedy

For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.

Products

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
Brand
Lone Star Medical Products, Inc
UPC
Lot #6000 (Serial numbers: 1480 thru 1489); Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); & Lot #6155 (Serial numbers: 1540 thru 1559).

Units Affected

40 units.