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Terminated

AVE 2 Birthing Bed

FDA Recall Z-0991-2019 · Posted None

Recalling FirmLinet Spol. S.r.o.
Recall StatusTerminated
Product CodeHDD
Date Initiated2019-01-07
Date Terminated2023-05-31
Product Quantity253 devices

Reason for Recall

LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

Firm Action

The firm disseminated their urgent correction notices on 01/07/2019 by mail. The notice discussed the potential safety issue and requested the consignee cease use of the bed if there was damage to the power cable. The firm will be providing a kit that includes a power cable hook and updated instruction for use.

Root Cause

Device Design

Distribution Pattern

AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX

Official Source

View FDA Recall →

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

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