Recall Z-1891-2017— PEROUSE MEDICAL

Name: FDA recall Z-1891-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-05

Class II · Terminated

Class II FDA medical device recall by PEROUSE MEDICAL, initiated 2017-04-05, terminated 2021-02-01. It names one FDA 510(k) clearance: K042449. Product: DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND. Reason: Complaints regarding broken blister..

Recalling firm: PEROUSE MEDICAL
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Terminated: 2021-02-01
Firm location: Ivry Le Temple, France

510(k) clearances named in this recall

1 on FDA's record

K042449 — DOLPHIN INFLATION DEVICESedat S.A.·cleared 2005-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Complaints regarding broken blister.

Data sourced from openFDA. This site is unofficial and independent of the FDA.