Recall Z-1671-2013— Boston Scientific Corporation

Name: FDA recall Z-1671-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class III · Terminated

Class III FDA medical device recall by Boston Scientific Corporation, initiated 2013-05-28, terminated 2014-02-10. It names one FDA 510(k) clearance: K050232. Product: RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.. Reason: Product labeled with incorrect expiration date..

Recalling firm: Boston Scientific Corporation
Classification: Class III
Status: Terminated
Initiated: 2013-05-28
Terminated: 2014-02-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K050232 — RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATORBoston Scientific Corp·cleared 2005-03-11

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

RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

Reason for recall

Product labeled with incorrect expiration date.

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