PlainRecordsFDA · Medical device recall
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters… and 1 more product
- Date posted by the FDA
- Feb. 15, 2011
- Status
- Terminated
- Filed by
- Ethicon Endo-Surgery Inc
- Reason
- The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.
- Distribution pattern
- Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.
2 products in this recall
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters…
- Product
- ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.
- Quantity
- 29,403 units
- Codes and lots
- The recalled Lot Numbers are: E4MJ47, E4MF6W, E4MK84, E4MM23, E4MM64, E4MP4A, E4MR15, E4MT07, E4MT4Y, F4MU2R, F4MY91, E4MG53, E4MG5K, E4MG5L, E4MN39, E4MG89, E4MG9M, E4MH2L, E4ML6J, E4MG77, E4MG8A, E4MH18, E4MJ3K, F4MX8C, and F4N799.
- Recall started
- March 27, 2009
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Root cause (FDA)
- Other
- What the company told customers
- Ethicon Endo-Surgery issued "Urgent Expanded Device Recall Event 1981" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. They are to complete and fax back the Business Reply Form, Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle, Replacement product should be received within 30-60 days after return, Customers can contact Stericycle concerning this recall at 1-888-365-4680, reference Event 1981.
- Recall number
- Z-1068-2011
FlexTray Procedure Delivery System…
- Product
- FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses.
- Quantity
- 135 kits
- Codes and lots
- Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V.
- Recall started
- March 27, 2009
- Device type
- Tray, Surgical
- Root cause (FDA)
- Other
- What the company told customers
- Ethicon Endo-Surgery issued "Urgent Expanded Device Recall Event 1981" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. They are to complete and fax back the Business Reply Form, Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle, Replacement product should be received within 30-60 days after return, Customers can contact Stericycle concerning this recall at 1-888-365-4680, reference Event 1981.
- Recall number
- Z-1069-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1068-2011, Z-1069-2011. The agency record governs; check it and the company before acting.