14CM ANGLE ATTACHMENT, BLACK MAX
This recall has been terminated (originally issued October 6, 2016).
- Company
- The Anspach Effort, Inc.
- Recall Initiated
- October 6, 2016
- Terminated
- July 26, 2019
- Recall Number
- Z-1974-2017
- Quantity
- 17
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Distribution
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Lot / Code Info
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14.
Root Cause
Under Investigation by firm
Action Taken
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.