FDA Medical Device Recalls (openFDA)
PEROUSE MEDICAL: DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
- Recall number
- Z-1891-2017
- Recalling firm
- PEROUSE MEDICAL
- Product
- DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
- Status
- Terminated
- Initiated
- 2017-04-05
- Posted
- not on file
- Terminated
- 2021-02-01
- Reason
- Complaints regarding broken blister.
- Root cause
- Packaging change control
- 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 iblayon@vvgon.com (CC mhpourriere@vygon.com); 7. Communicate the safety information to any person concerned in your company and to all end customers to which the product were transferred.
- Quantity
- 18,431
- Distribution
- US: AZ (shipped through Belgium to USA), MN, TN
- Lot, serial or model codes
- 1 5045606 - 15055430 - 15065340 - 15065685 -15065744- 15065858- 15065970- 15075121 - 15075265 - 15075411- 15075821 - 1 5075851 - 15075942 - 15085001 - 15085075 -15085378- 15085435 -15085515- 15085555 -15105052- 15125214- 16015267- 16025034- 16025640
- 510(k) numbers
- ["K042449"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 3006942524
- Firm city
- Ivry Le Temple
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28