FDA Device Recall Z-0918-2022

Sensory Medical Inc · Lakewood, CO

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Cub 2 Enclosed Bed Canopy System

Lot / serial / GTIN: Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.

Quantity: 225 devices

Reason for recall

Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.

Recall record

Recall number: Z-0918-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: U.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA. MD, MI, MN, MO. MS. NC, ND, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, and WI; and O.U.S Internationally to: Canada
Recall initiated: 2022-03-14
Classified by FDA Center: 2022-04-14
FDA published: 2022-04-20
Recalling firm: Sensory Medical Inc
Firm location: Lakewood, CO

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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