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 cdrrhrprsdd@yahoo.com.
Dissemination of the information to all concerned is requested.