KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Use
FDA device recall Z-0866-2015 · posted 2014-12-24 · Terminated
Recall details
- Recalling firm
- Halyard Health
- Reason for recall
- The cuff inflation line may detach from the endotracheal tube during use.
- Action taken
- The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 430 cases (10 tubes per case)
- Distribution
- Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., F
- Date initiated
- 2014-11-17
- Date posted
- 2014-12-24
- Date terminated
- 2015-08-18
- Location
- Roswell, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (K131254) | Kimberly-Clark Corp. | 2013-08-20 |