FDA · Medical device recall

Impervious Stockinette… and 5 more products

Sept. 29, 2004

Date posted by the FDA: Sept. 29, 2004
Status: Terminated
Filed by: Deroyal Surgical -Rose Hill
Reason: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
Distribution pattern: Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.

6 products in this recall

Impervious Stockinette…

Product: Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
Quantity: 1971 cases
Codes and lots: Lot # 1007298 1007335 1007360 1030228 1030244 1045526 1049113 1081519 1107441 1141972 1161316 1161332 1200979 1225252 1306538 1310369 1315021 1330597 1330600 1342811 1375681 1375808 1375816 1490540 1504008 1504032 1521713 1543630 1571438 1650988 1736028 1759511 1802072 1911543 1911615 2076658 2076738 2137810 2137828 2138062 2187067 2228121 2376204 2701345 765821 765855 804316 805431 805440 825580 825598 825635 825643 850507 900691 932991 933071 933097 933118 933151 950663 950680 950743 974585 974593 974665
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1490-04

Stockinette…

Product: Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72.
Quantity: 1 case
Codes and lots: Lot: 1503929
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1491-04

Stockinette…

Product: Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60
Quantity: 19 cases
Codes and lots: Lots: 1030279 1600315 929506 929514
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1492-04

Stockinette…

Product: Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
Quantity: 709 cases
Codes and lots: Lot: 1007212 1030172 1030181 1142043 1225324 1225332 1225341 1225359 1306298 1330669 1330677 1341190 1375832 1375841 1375867 1375875 1407072 1431304 1521772 1543672 1543681 1627016 1634152 1678542 1678606 1736079 1736087 1736095 1736108 1736116 1800384 1800608 1876426 1911375 1911421 2055689 2075217 2136454 2136471 2268684 2375877 728683 783421 805360 805378 805482 825555 900762 900797 900800 974681 974729
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1493-04

Stockinette…

Product: Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72
Quantity: 395 cases
Codes and lots: Lots: 9984-54 9985-60 9991-60 9986-72 9987-48 9988-72
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1494-04

Stockinette…

Product: Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60
Quantity: 3 cases
Codes and lots: Lot: 932924 1330482 1407048
Recall started: Sept. 9, 2004
Device type: Drape, Surgical, Antimicrobial
Root cause (FDA): Other
What the company told customers: The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Recall number: Z-1495-04

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1490-04, Z-1491-04, Z-1492-04, Z-1493-04, Z-1494-04, Z-1495-04. The agency record governs; check it and the company before acting.

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