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All are hereby advised by the Food and Drug Administration (FDA) about the voluntary recall of the following lot numbers of Proximate HCS Procedure for Prolapse and Hemorrhoids (PPH) Set, Codes PPH01 and PPH03 (see figures 1, 2 and 3), with product registration number DVR-4945. The said products were imported and distributed by Johnson & Johnson (Philippines), Inc. with office address at Edison Rd., Bo. Ibayo, Parañaque City.

PRODUCT NAME PRODUCT CODE  

PRODUCT LOTS

Proximate HCS Hemorrhoidal Circular Stapler  

PPH01

P9461W
P94K20
 
Proximate PPH Hemorrhoidal Circular Stapler PPH03 P93K95 P9420Y P94A4T
P93L1M P9420Z P94D3N
P93M3G P9441H P94F3Z
P93T35 P9450L P94G04
P93T7F P9463J P94H5F
P93W3M P94765 P94J4W
P93W3N P9487Z P94J80
P93Y58 P94901 P94K2A
P94117 P94A20 R9200Z

The above-stated medical device products are being voluntary recalled by Johnson & Johnson (Philippines), Inc. because the manufacturer, Ethicon Endo-Surgery, LLC, has confirmed that some devices contained in the affected lots may have been assembled without a washer. The medical assessment concluded that this situation may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired.

Distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product.

Any suspected adverse reaction experienced from the use of the device but not limited to the lot stated above, should be reported immediately to FDA at telephone number (02) 857-1900 local 8301 or email us at [email protected]yahoo.com.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-077