Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oakworks Bed (Emergency Field Bed)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Oakworks Bed (Emergency Field Bed) see related information
Date Initiated by Firm April 21, 2022
Create Date June 06, 2022
Recall Status1 Open3, Classified
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-