• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 65321
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006134, 1101020, 1106424 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 2,980 units (298 boxes) Z-1489-2013
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 48,040 units, ( 4804 boxes) Z-1490-2013
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1007157, 1103202 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 1,980 units (198 boxes) Z-1491-2013
Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005111, 1011282,1107491, 1107492 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 3,000 units (300 boxes) Z-1492-2013
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 34,640 units (3,464 boxes) Z-1493-2013
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 21,660 units (2166 boxes) Z-1494-2013
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 7960 units (796 boxes) Z-1495-2013
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005097, 1009205, 1011294, 1102105, 1104268, 1106463, 1108633, 1109857, 1005098, 1009219, 1012313, 1102109, 1104305, 1106465, 1108648, 1109812, 1005104, 1008192, 1011281, 1102119, 1104307, 1106470, 1108654, 1109860, 1005105, 1009213, 1012325, 1102123, 1104308, 1107493, 1108659, 1109817, 1005110, 1009197, 1012327, 1102141, 1104320, 1107488, 1108666, 1005111, 1009204, 1012335, 1102147, 1104327, 1107497, 1108667, 1005118, 1010227, 1012345, 1102150, 1105370, 1106474, 1108671, 1006123, 1010234, 1101014, 1103170, 1105342, 1107511, 1108675, 1007155, 1010235, 1012344, 1103171, 1105356, 1107512, 1108701, 1006127, 1010251, 1101003, 1103223, 1105110, 1107516, 1108704, 1006133, 1010258, 1101017, 1103189, 1105379, 1107537, 1109778, 1006140, 1010243, 1101002, 1103194, 1105390, 1107546, 1107520, 1008181, 1012314, 1101029, 1103184, 1105401, 1107595, 1108710, 1007163, 1010259, 1101046, 1103227, 1106418, 1107604, 1108713, 1007145, 1010252, 1101053, 1104280, 1106432, 1107561, 1109740, 1007156, 1011266, 1102073, 1104248, 1106453, 1108624, 1109750, 1007169, 1011267, 1102092, 1104259, 1106444, 1107599, 1109729, 1007151, 1011275, 1101055, 1104264, 1106451, 1107567, 1109735, 1008176, 1011280, 1102085, 1104290, 1106437, 1107578, 1109755, 1008178, 1011295, 1102099, 1104278, 1106455, 1107570, 1109781, 1008188, 1011276, 1102080, 1104283, 1106460, 1108619, and 1109809. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 334,520 units (33,452 boxes) Z-1496-2013
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1007145, 1101004, 1107487 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 3000 units (300 boxes) Z-1497-2013
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005098, 1010228, 1012337, 1105367 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 3,980 units ( 398 boxes) Z-1498-2013
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 25,770 units (2,577 boxes) Z-1499-2013
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006141, 1012303, 1102110, 1104324, and 1108664 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 5,000 units ( 500 boxes) Z-1500-2013
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1105390, 1107543 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 9,930 units (993 boxes) Z-1501-2013
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 88,040 units (8,804 boxes) Z-1502-2013
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1010236, 1108682 Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 2,000 units ( 200 boxes) Z-1503-2013
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. 1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634. Class II Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present. 6,990 units ( 699 boxes) Z-1504-2013
-
-