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Cook brand Zenith AAA Iliac leg graft with the H&L-B… recallZ-1191-04 · Cook, Inc. · initiated Jun 10, 2004

Terminated All recalls posted in July 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cook, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDA root cause category: Other

What the company is doing

The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

Recall details

Recall number
Z-1191-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 10, 2004
Posted by the FDA
Jul 27, 2004
Recalling firm
Cook, Inc.
Quantity
63
Product code
MIH
FDA submissions
P020018
Distribution
Nationwide, Canada, Denmark and Japan.

Product description

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-14-88.

Code information (models, lots, serial numbers)

Lots 1359997, 1359996, F1548692, F1550342, F1550343, F1550344, F1550345, F1550346, F1548694, F1548695, F1548696, F1549764, F1542546, F1542547, F1555397, F1555398, F1553439, F1553440, F1553441, F1553442, F1553443, F1559075, F1559076, F1550342, F1561392, F1561393, F1559077, F1559078, F1559079, F1559080, F1559081, F1559082, F1564166, F1564167, F1561394, F1561395, F1561396, F1564366, F1564365, F1564367, F1564368, F1566689, F1565773, F1565774, F1565775, F1565776, F1565777, F1569274, F1570171, F1566690, F1566691, F1566692, F1571041, F1571042, F1570172, F1570173, F1570175, F1572974, F1571044, F1571045, F1575308, F1575312 and F1570174.

Other devices under the same FDA submission

36 devices cleared under P020018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 29300).

Sources and updates

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