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U.S. Department of Health and Human Services

Class 2 Device Recall Tollos

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 Class 2 Device Recall Tollossee related information
Date Initiated by FirmOctober 24, 2022
Date PostedNovember 17, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0245-2023
Recall Event ID 91000
Product Classification Lift, patient, ac-powered - Product Code FNG
ProductInfection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
Code Information UDI-DI 00817956021 (not yet uploaded to GUDID)
FEI Number 3008406502
Recalling Firm/
Manufacturer		 Tollos
8 Easter Ct Ste J
Owings Mills MD 21117-3294
For Additional Information ContactTheresa Stewart
410-3631515
Manufacturer Reason
for Recall		Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).
FDA Determined
Cause 2		Equipment maintenance
ActionOn October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. The firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed. Access complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins. Tollos can be contacted by e-mail at service@tollos.com.
Quantity in Commerce1273 US; 70 OUS
DistributionWorldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
Total Product Life CycleTPLC 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.
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