RECALLS AND FIELD CORRECTIONS 6

RECALLS AND FIELD CORRECTIONS 6 - ENFORCEMENT REPORT FOR...

Info iconThis preview shows pages 1–3. Sign up to view the full content.

View Full Document Right Arrow Icon
ENFORCEMENT REPORT FOR SEPTEMBER 15, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I ___________________________________ PRODUCT Hospira Inc. Symbiq One- and Two- Channel Infuser. Recall # Z-2381-2010 CODE List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13- 25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54 RECALLING FIRM/MANUFACTURER Recalling Firm: Hospira, Inc., Morgan Hill, CA, by letter on March 26, 2010. Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing. REASON If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result. VOLUME OF PRODUCT IN COMMERCE 28,485 units DISTRIBUTION Nationwide, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT Microwave Ovens, Model Number DG-2. Recall # Z-2114-2010 CODE Accession number: 0930317-000 RECALLING FIRM/MANUFACTURER Duke Manufacturing Co., Saint Louis, MO, by letter on May 12, 2010. Firm initiated recall is ongoing. REASON The oven did not meet Federal Performance Standard for certain requirements. VOLUME OF PRODUCT IN COMMERCE 62 units DISTRIBUTION Nationwide
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
ENFORCEMENT REPORT FOR SEPTEMBER 15, 2010 ___________________________________ PRODUCT 1) SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, Qty. 1. Sterile. Part number 904008. Used to pass suture through tissue. Recall # Z-2228-2010; 2) SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, Qty. 1. Sterile. Part number 904010. Used to pass suture through tissue. Recall # Z-2229-2010; 3) SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, Qty. 1. Sterile. Part number 904012. Used to pass suture through tissue. Recall # Z-2230-2010; 4) Suture Lariat 30 Degree Up, Qty. 1. Sterile. Part number 904022. Used to pass suture through tissue. Recall # Z-2231-2010; 5) Suture Lariat 45 Degree Dog Leg Up, Qty. 1. Sterile. Part number 904025. Used to pass suture through tissue. Recall # Z-2232-2010 CODE 1) Lot numbers: 863940 and 863950; 2) Lot numbers: 050260, 863960, and 863970; 3) Lot numbers: 863920 and 863930; 4) Lot numbers: 863990 and 864010; 5) Lot numbers: 864020 and 864030 RECALLING FIRM/MANUFACTURER Biomet, Inc. Warsaw, IN, by letter on June 18, 2010. Firm initiated recall is ongoing. REASON The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery. VOLUME OF PRODUCT IN COMMERCE
Background image of page 2
Image of page 3
This is the end of the preview. Sign up to access the rest of the document.

Page1 / 17

RECALLS AND FIELD CORRECTIONS 6 - ENFORCEMENT REPORT FOR...

This preview shows document pages 1 - 3. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online