Date Initiated by Firm | April 21, 2022 |
Create Date | June 06, 2022 |
Recall Status1 |
Terminated 3 on September 19, 2024 |
Recall Number | Z-1239-2022 |
Recall Event ID |
90172 |
Product Classification |
Bed, manual - Product Code FNJ
|
Product | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS |
Code Information |
UDI-DI: n/a
Serial Numbers:
PWK769356
PWK769357
PWK769358
PWK769359
PWK769360
PWK769361
PWK769362
PWK769363
PWK769364
PWK769365
PWK769366
PWK769367
PWK769368
PWK769369
PWK769370
PWK769371
PWK769372
PWK769373
PWK769374
PWK769375
PWK769376
PWK769377
PWK769378
PWK769379
PWK769380
PWK769381
PWK769382
PWK769383
PWK769384
PWK769385
PWK769386
PWK769387
PWK769388
PWK769389
PWK769390
PWK769391
PWK769392
PWK769393
PWK769394
PWK769395
PWK769396
PWK769397
PWK769398
PWK769399
PWK769400
PWK769401
PWK769402
PWK769403
PWK769404
PWK769405
PWK769406
PWK769407
PWK769408
PWK769409
PWK769410
PWK769411
PWK769412
PWK769413
PWK769414
PWK769415
PWK769416
PWK769417
PWK769418
PWK769419
PWK769420
PWK769421
PWK769422
PWK769423
PWK769424
PWK769425
PWK769426
PWK769427
PWK769428
PWK769429
PWK769430
PWK769431
PWK769432
PWK769433
PWK769434
PWK769435
PWK769436
PWK769437
PWK769438
PWK769439
PWK769440
PWK769441
PWK769442
PWK769443
PWK769444
PWK769445
PWK769446
PWK769447
PWK769448
PWK769449
PWK769450
PWK769451
PWK769452
PWK769453
PWK769454
PWK769455
PWK769456
PWK769457
PWK769458
PWK769459
PWK769460
PWK769461
PWK769462
PWK769463
PWK769464
|
Recalling Firm/ Manufacturer |
Oakworks Inc 923 E Wellspring Rd New Freedom PA 17349-8408
|
For Additional Information Contact | Stephen McKinley 717-235-6807 |
Manufacturer Reason for Recall | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs. |
FDA Determined Cause 2 | Error in labeling |
Action | On April 21, 2022, the firm notified customers via mail and email of the field action.
Customers should identify and locate all affected products. Distributors should quarantine the product and notify any customers who have received the product. For users, the product remains functional and can continue to be used. All customers should complete the included response form and return to Oakworks. Oakworks will set up a service visit to replace the labels on the affected beds.
If you have any questions or concerns, please contact Oakworks Customer Service Department at 800-558-8850 or 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time. |
Quantity in Commerce | 109 |
Distribution | US Nationwide distribution in the states of MA, NJ, and PA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|