medical Class II Updated 2019-08-14

ROi Consolidated Service Center (CSC) recalls Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF

Recalled Product

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Hazard / Issue

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Issued by

FDA

Affected States: LA, MO

Lot/Code Info: Item Number (Lot Number, Expiration Date): 800096004 (044343D, 43590); 800096004 (048023D, 43722); 800096004 (049262D, 43757); 800096004 (052020D , 43856); 800096004 (054482D, 43948); 800096004 (057619D, 44035); 800096005 (059908E , 44080); 800096005 (062938E , 44151); 800096005 (65606E, 44232);

View official government recall

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