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Terminated

Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall Z-0024-2009 · Posted 2008-10-07

Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeHET
Date Initiated2008-06-25
Date Terminated2012-03-26
Product Quantity14,113 total

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).

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide and Canada distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012884DILATING TIP OBTURATORApplied Medical Resources Corp. · 2002-01-17K945741TROCAR AND CANNULA ACCESSORYApplied Medical Resources · 1995-02-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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