AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatmen
FDA device recall Z-2045-2020 · posted 2020-01-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
- Action taken
- On December 17, 2019, the firm sent an Urgent Medical Device Product Advisory letter to affected customers. Customers were informed of the labeling mix-up and instructed to add the advisory notice to the patient record. Customers were also asked to complete and returned an enclosed acknowledgement form. Customers with questions should contact their local Sales Representative.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JCW
- Quantity affected
- 5
- Distribution
- US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
- Date initiated
- 2019-12-17
- Date posted
- 2020-01-28
- Date terminated
- 2020-06-04
- Location
- Marlborough, MA
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