Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
FDA device recall Z-1404-2015 · posted 2015-04-08 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
- Action taken
- Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected listed catalog numbers and to return the product. Complete the enclosed acknowledgement form to Teleflex Medical. The form is to be returned even if they have not products. For further questions contact your local sales representative or Customer Service at 1-866 246-6990.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDQ
- Quantity affected
- 2,148 units
- Distribution
- US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.
- Date initiated
- 2015-03-13
- Date posted
- 2015-04-08
- Date terminated
- 2017-08-14
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR (K962856) | Deknatel, Inc. | 1996-08-28 |