Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohi

FDA device recall Z-2995-2018 · posted 2018-09-07 · Terminated

Recall details

Recalling firm

Ohio Medical Corporation

Reason for recall

The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.

Action taken

The firm, Ohio Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to customer.service@ohiomedical.com for additional instructions to replace the wiring harness; and complete the attached Customer Acknowledgement Form and return it to our Quality Assurance Department at 847/855-6304 (fax), email to: CEV3_FCA@ohiomedical.com, or mail in the envelope provided to: Ohio Medical LLC, ATTN: Quality Assurance Department, 1111 Lakeside Drive, Gurnee, IL 60031. Please direct questions to Sr. Director, QA/RA at 847-855-6326 or email: barbara-ann.conway-myers@ohiomedical.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BTA

Quantity affected

1443 units

Distribution

US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.

Date initiated

2018-08-14

Date posted

2018-09-07

Date terminated

2020-12-15

Location

Gurnee, IL

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