Apparatus, Suction, Operating-room, Wall Vacuum Powered

STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Chest Drainage Units and Accessories:

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgi

Incomplete or partial pouch seals, which may result in a breach in the sterility.

CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA.

Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.