Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Reported: May 4, 2016 Initiated: March 30, 2016 #Z-1582-2016
Product Description
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Reason for Recall
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 12,124 ea.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use. Recalled by Teleflex Medical. Units affected: 12,124 ea..
Why was this product recalled? ▼
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1582-2016.
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