Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. M

FDA device recall Z-0167-2014 · posted 2013-11-05 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.

Action taken

Invacare sent an Urgent Medical Device Recall Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge their receipt and understanding of the urgent recall notice and indicate the number of affected product in their inventory on the enclosed Provider Response Card. Customers were instructed to examine their existing stock and quarantine any affected product and fax the completed Provider Response Card immediately to Invacare Corporation at 440-326-3544. Customers were responsible for ensuring that the recall was conducted to the customer level. Correction kits were provided to the customers with the communication. Customers were instructed to document the correction details on the enclosed Product Tracking Sheet and fax to Invacare Customer Service at 440-326-3544. For questions regarding this recall call 440-329-3544.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

INN

Quantity affected

538 (US only) 3317 (Total)

Distribution

Worldwide Distribution - USA including PA and Internationally to Canada.

Date initiated

2013-08-31

Date posted

2013-11-05

Date terminated

2014-09-15

Location

Elyria, OH