Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.

FDA Recall Z-0805-05 · Posted 2005-05-12

Recalling FirmLaerdal Medical Corporation
Recall StatusTerminated
Product CodeLDD
Date Initiated2005-04-29
Date Terminated2008-01-18
Product QuantityAt least 3,019 units sold in the U.S.

Reason for Recall

Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.

Firm Action

Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution.

Official Source

View FDA Recall →

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

↑