Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

FDA Recall Z-1308-2018 · Posted 2018-04-04

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeEZD
Date Initiated2017-09-14
Date Terminated2019-11-05
Product Quantity10,949,013 units in total

Reason for Recall

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Firm Action

A notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.

Root Cause

Process control

Distribution Pattern

US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122785HYDROSIL; MAGIC; PERSONAL CATHETERRochester Medical Corp. · 2013-05-14K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp. · 2000-05-19

Official Source

View FDA Recall →

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

↑