Recall Z-2418-2023— Carefusion 2200 Inc

Name: FDA recall Z-2418-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Class II · Ongoing

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2023-07-13. It names one FDA 510(k) clearance: K930667. Product: Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device. Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-07-13
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K930667 — REUSABLE LAPAROSCOPIC INSTRUMENTSSnowden-Pencer·cleared 1994-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device

Reason for recall

Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

Data sourced from openFDA. This site is unofficial and independent of the FDA.