Recall Z-0833-2022 ยท HET Laparoscope, Gynecologic (And Accessories)
Carefusion 2200 Inc
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.
| Date | Feb 23, 2022 |
| Status | Terminated |
| Reason | The finished device package did not contain the IFU. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters dated 2/23/2022 on the same date via email and FedEx 2 day delivery. The letter described the issue and the health hazards involved and requested the consignee to take the following actions: (1) Check all inventory locations for the affected catalog/lot numbers; (2) The IFU is provided with the letter and the consignee is requested to maintain it in the appropriate location as determined by their facility. If more than one IFU is required, the consignee is to contact BD; (3) Share the recall notice with any users of the product within their facility to ensu |
| Quantity | 152 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982276 | BAHO AUTOCLAVABLE LAPAROSCOPE Microptix Int'L, LLC, Feb 18, 1999 |