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Terminated

APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.

FDA Recall Z-0192-05 · Posted 2004-11-11

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2004-09-15
Date Terminated2007-06-19
Product Quantity2321 units

Reason for Recall

rotating knob of the rotary style APL valve can become separated from the assembly.

Firm Action

The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.

Root Cause

Other

Distribution Pattern

The product was shipped to medical supply companies, medical facilities nationwide. The product was also shipped to a government accounts in AR, FL, ID, LA, MA, MD, ME, NC, NY, OH, TX, VA, and VT. The product was also shipped to Canada, Germany, Korea, China, Australia, Singapore, Switzerland, and England

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041266PEDIATRIC REFERENCE DATABASEHologic, Inc. · 2004-08-11K033498NARKOMED 6400, MODEL NM6400Draeger Medical, Inc. · 2004-04-26

Official Source

View FDA Recall →

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

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