—#35202

Product

Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K993691
Affected lot / code info: Lot number RF4066579

Why it was recalled

Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.

Timeline

Recall initiated: 2004-09-27
Posted by FDA: 2004-10-28
Terminated: 2004-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.