FDA (Devices) recall action 67711
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.
Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.
Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.
Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.
Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.
Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.
Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.