| Class 2 Device Recall Cardinal Health JacksonPratt Channel Drain 15FR | |
Date Initiated by Firm | June 28, 2019 |
Create Date | August 12, 2019 |
Recall Status1 |
Terminated 3 on October 22, 2020 |
Recall Number | Z-2262-2019 |
Recall Event ID |
83287 |
Product Classification |
Catheter, irrigation - Product Code GBX
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Product | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar
Product Number: JP-2189
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. |
Code Information |
Lot Codes: P1841752 P1852268 P1845823 |
Recalling Firm/ Manufacturer |
Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
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Manufacturer Reason for Recall | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body |
FDA Determined Cause 2 | Process control |
Action | Degania Silicone Ltd. notified accounts by letter dated June 28, 2019 describing the problem, health risk and action to take: Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list.2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession.
3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: kkayam@qco.net. 4. Disposition of the recalled product:
- the preferred option for us is to scrap any recalled product at your facility. In this case we will require official Destruction Confirmation letter containing details of the scrapped product, signed by your company (the draft will be provided by request). - if the above option is not acceptable, we would ask to return any recalled product to our Rhode Island facility.
Questions contact Degania Silicone:
Degania Silicone Ltd. Degania Bet, 1513000, Israel Katia Kayam, Customer complaints Officer Tel: +972-529532059 E-mail: Kkayam@qco.net |
Quantity in Commerce | 6080 |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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