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Terminated

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND

FDA Recall Z-1891-2017 · Posted None

Recalling FirmPEROUSE MEDICAL
Recall StatusTerminated
Product CodeMAV
Date Initiated2017-04-05
Date Terminated2021-02-01
Product Quantity18,431

Reason for Recall

Complaints regarding broken blister.

Firm Action

Consignees were notified of the recall on April 5, 2017. They were informed of the issue and asked to take the following steps: 1. Inspect your stock to determine if you still have in your ownership devices among which the references and batch codes are listed in front page; 2. Control the potential damage of the blister according to the pictures above and the instructions mentioned on the labeling and the Instruction For Use: any damaged and/or cracked blister must be immediately discarded; 3. Use the compliant products without risk, after control. Indeed, the primary packaging will not deteriorate in time. If, to date, there is no crack in the blister, then the integrity of the product is not compromised; 4- Do not use the non-compliant products; 5. Complete and sign the attached reply form, then return it within 5 working days following the reception of this letter, and keep a copy; 6. Contact customer service for the modalities of return, replacement and associated support at +33 (0)4.72.39.74.13 or by fax at +33 (0}3.44.08.17.67 or by email at [email protected] (CC [email protected]); 7. Communicate the safety information to any person concerned in your company and to all end customers to which the product were transferred.

Root Cause

Packaging change control

Distribution Pattern

US: AZ (shipped through Belgium to USA), MN, TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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