Course 2 Device Remember Bard 100 LatexFree Urinary Drainage Purse with AntiReflux Chamber and Bard EXLok Sampling
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| | Grade 2 Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Bedroom and Bard EXLok Sampling |  | | Appointment Initiated past Business firm | January 30, 2015 | | Appointment Posted | April 01, 2015 | | Recall Status1 | Terminated iii on Baronial 01, 2016 | | Recall Number | Z-1358-2015 | | Recall Event ID | 70666 | | Production Classification | Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
| | Product | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671 | | Lawmaking Data | Lot Numbers NGYJ0603 and NGYJ1671 | Recalling Business firm/
Manufacturer | C.R. Bard, Inc.
8195 Industrial Blvd Ne
Covington GA 30014-1497
| | For Additional Information Contact | Sherry Saurini
770-784-6119 | Manufacturer Reason
for Recall | Potential breach of the sterile barrier packaging. | FDA Determined
Crusade 2 | Unknown/Undetermined past business firm | | Activity | Bard sent an Urgent Medical Device Remember letter on January 30, 2015, to all affected customers. The letter of the alphabet identified the product the problem and the action needed to be taken by the client. The letter likewise requested that a sub-recollect should be conducted if the product was further distributed. The alphabetic character besides included a response course which is to exist returned to Bard. This voluntary recall is only for the lots noted in a higher place with the affected product itemize number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you lot take further distributed this product, you lot are required to notify your accounts of the voluntary think. If y'all accept whatsoever questions or need assistance in notifying your accounts about the correction, please call ane-770-784-6471. We appreciate your cooperation and assistance in dealing with this matter and sincerely repent for any inconvenience that may event from this action. | | Quantity in Commerce | 9,620 units | | Distribution | Nationwide Distribution to u.s. of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, Medico, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA. | | Total Product Life Bicycle | TPLC Device Report |
| one A record in this database is created when a firm initiates a correction or removal action. The tape is updated if the FDA identifies a violation and classifies the action equally a remember, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
ii Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
three For details near termination of a recall see Lawmaking of Federal Regulations (CFR) Title 21 §7.55. | |
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Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134365
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