Medical Device Recall: Z-0008-04

FDA Recalls dataset · Firm: Rultract Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-18 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-04.

Recall Res Number
Z-0008-04
Recalling Firm / Manufacturer
Rultract Inc
FEI Number
3000717741
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-18
Date Posted
2003-10-15
Date Terminated
2007-03-23
Product Code
DWS
Event Number
27177
Product Quantity
2,718 units
Product Description Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Reason for Recall Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
Action Details The firm notified their affected consignees by letter on 9/18/2003.
Distribution Pattern The device was distributed to end-users located nationwide.
Code Information / Serial Numbers S/Ns: 0001 to 2005, and S/Ns: 2172 to 2885

Related Establishments / Registrations

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