[Recalled] Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity. — The defective component can cause gas leakage through the device | FDA 2015-10-14

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Teleflex Medical

• ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. — Class I
• HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation. — Class I
• ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is inte — Class II
• Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor . — Class II
• Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue — Class II
• Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.