Z-1891-2017Class II

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND...

Name: Z-1891-2017 DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND...
Creator: Perouse Medical
Published: 2017-04-05
License: https://open.fda.gov/license/

Perouse Medical / initiated 2017-04-05 / Terminated / root cause: packaging

FDA source

PEROUSE MEDICAL began a recall of DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA... on 2017-04-05. FDA classified it as Class II and gives the reason as "Complaints regarding broken blister". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1891-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Posted: 2017-04-28
Terminated: 2021-02-01
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
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Complaints regarding broken blister.
Root cause tag: packaging
FDA 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 [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.
Quantity in commerce: 18,431
Distribution: US: AZ (shipped through Belgium to USA), MN, TN
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1891-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-04-28

Product code MAV

K042449Class IIDolphin Inflation DeviceSedat S.A. / cleared 2005-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)