FDA Device Recall Z-0026-2009: Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-2009.

Recall Res Number

Z-0026-2009

Recalling Firm / Manufacturer

Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

FEI Number

2027111

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-06-25

Date Posted

2008-10-07

Date Terminated

2012-03-26

Product Code

HET

Event Number

49445

Product Quantity

14,113 total

Product Description Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Reason for Recall Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).

Action Details Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.

Distribution Pattern Nationwide and Canada distribution.

Code Information / Serial Numbers Product/Kit Batch Numbers: 1060178, 1056644, 1056045

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Medical Device Recall: Z-0026-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer