Z-0181-04
Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers...
Bock,Otto,Orthopedic Ind,Inc / initiated 2003-10-29 / Terminated
Bock,Otto,Orthopedic Ind,Inc began a recall of Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012... on . The reason FDA records is "Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0181-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Bock,Otto,Orthopedic Ind,Inc
- Product
- Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
- Product code
- IOR Wheelchair, Mechanical
- Reason for recall
- Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
- FDA root cause
- Other
- Action
- Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.
- Distribution
- The product was distributed nationwide in the United States and to Canada and Mexico.
- Product codes and lots
- The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
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