Recall Z-0832-2012 ยท NZG Bassinet, Hospital
Nemschoff Chairs, Inc.
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.
| Date | Feb 1, 2012 (initiated Oct 14, 2011) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.