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Terminated

Vail 2000 Enclosed Bed System.

FDA Recall Z-0863-05 · Posted 2005-06-30

Recalling FirmVail Products Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated2005-05-06
Date Terminated2011-01-05
Product Quantity1004 beds in distribution.

Reason for Recall

Risk of patient entrapment, may result in serious injury or death.

Firm Action

The recalling firm sent consignees an urgent notification letter, dated 5/6/05.

Root Cause

Device Design

Distribution Pattern

Nationwide, Puerto Rico, Canada and Saudi Arabia. MA, RI, NH, ME, VT, CT, NJ, NY, PA, DE, Washington DC, VA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, and AK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963622VAIL 2000 ENCLOSED BEDVail Products, Inc. · 1997-05-07

Official Source

View FDA Recall →

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

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