Recall Z-2995-2018
Ohio Medical Corporation · initiated August 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
Codes / lots: (a) style 758010 Serial Numbers: CDS5000 CDS5001 CDS5002 CDS5003 CDS5004 CDS5005 CDS5006 CDS5007 CDS5008 CDS5009 CDS5010 CDS5011 CDS5012 CDS5013 CDS5014 CDS5015 CDS5016 CDS5017 CDS5018 CDS5019 CDS5020 CDS5021 CDS5022 CDS5023 CDS5024 CDS5025 CDS5026 CDS5027 CDS5028 CDS5029 CDS5030 CDS5031 CDS5032 CDS5033 CDS5034 CDS5035 CDS5036 CDS5037 CDS5038 CDS5039 CDS5040 CDS5041 CDS5042 CDS5043 CDS5044 CEV3X0076 CEV3X0077 CEV3X0078 CEV3X0079 CEV3X0080 CEV3X0081 CEV3X0082 CEV3X0083 CEV3X0084 CEV3X0085 CEV3X0086 CEV3X0087 CEV3X0088 CEV3X0089 CEV3X0090 CEV3X0091 CEV3X0092 CEV3X0093 CEV3X0094 CEV3X0095 CEV3X0096 CEV3X0097 CEV3X0098 CEV3X0099 CEV3X0100 CEV3X0101 CEV3X0102 CEV3X0103 CEV3X0104 CEV3X0105 CEV3X0106 CEV3X0107 CEV3X0108 CEV3X0109 CEV3X0110 CEV3X0111 CEV3X0112 CEV3X0113 CEV3X0114 CEV3X0115 CEV3X0116 CEV3X0117 CEV3X0118 CEV3X0119 CEV3X0120 CEV3X0121 CEV3X0122 CEV3X0123 CEV3X0124 CEV3X0125 CEV3X0176 CEV3X0177 CEV3X0178 CEV3X0179 CEV3X0180 CEV3X0181 CEV3X0182 CEV3X0183 CEV3X0184 CEV3X0185 CEV3X0186 CEV3X0187 CEV3X0188 CEV3X0189 CEV3X0190 CEV3X0191 CEV3X0192 CEV3X0193 CEV3X0194 CEV3X0195 CEV3X0196 CEV3X0197 CEV3X0198 CEV3X0199 CEV3X0200 CEV3X0201 CEV3X0202 CEV3X0203 CEV3X0204 CEV3X0205…
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2995-2018
- Initiated
- August 14, 2018
- Posted by FDA
- September 7, 2018
- Terminated
- December 15, 2020
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 1443 units
- Distribution
- US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.
- Recalling firm
- Ohio Medical Corporation, Gurnee, IL