Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Reported: July 8, 2020 Initiated: April 24, 2020 #Z-2451-2020
Product Description
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Reason for Recall
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
Details
- Recalling Firm
- LivaNova USA Inc.
- Units Affected
- 600 units
- Distribution
- US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
- Location
- Arvada, CO
Frequently Asked Questions
What product was recalled? ▼
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276. Recalled by LivaNova USA Inc.. Units affected: 600 units.
Why was this product recalled? ▼
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2451-2020.
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