Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled...
Nemschoff Chairs, Inc. began a recall of Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray... on . The reason FDA records is "To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0832-2012
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Nemschoff Chairs, Inc.
- Product
- Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
- Product code
- NZG Bassinet, Hospital
- Reason for recall
- To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.
- Quantity in commerce
- 1214 units.
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.
- Product codes and lots
- Model BSNT/01 and BSNT/02 manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
