9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Por
FDA device recall Z-1536-2017 · posted 2017-03-08 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
- Action taken
- Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 71 units
- Distribution
- Worldwide Distribution to PR and Panama
- Date initiated
- 2017-02-23
- Date posted
- 2017-03-08
- Date terminated
- 2018-02-02
- Location
- Harleysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDCOMP GEN III POWER INJECTABLE PORT (K132177) | Medcomp ( Medical Components) | 2013-12-12 |