Suture, Nonabsorbable, Synthetic, Polyamide

Dermalon

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

TISSUE APPROXIMATION SYSTEM (TAS),

Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.

Surgilon Braided Nylon sutures:

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

Dermalon Monofilament Nylon Suture:

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Monosof Monofilament Nylon sutures:

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Surgilon Braided Nylon suture

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is

Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.

Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel.

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes.

Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.