Teleflex Medical: Sterility: Due to a potential incomplete seal on the outer sterile package.

Agency Publication Date: November 30, 2016

Affected Products

Product: 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 intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

Material # 9408-VC-006, Lot numbers: 010256, 010257, 010438, 010439, 010556, 010557, 010737, 010738, 010739, 010946, 010947, 011037, 011046, 011047, 011048, 011215, 011216, 011217, 011380, 011381, 011383, 011384, 011385, 011675, 011676, 011945, 011946, 011947, 012139, 012140, 012141, 012142, 012353, 012354, 012355, 012356, 012463, 012464, 012465, 012570, 012572, 012573, 012686, 012687, 012688, 012895, 012896, 013074, 013084, 013085, 013122, 013185, 013255, 013256, 013257, 013258, 013477, 013478, 013688, 013894, 013895, 013896, 013897, 014111, 014112, 014113, 014114, 014115, 014134, 014135, 014136, 014199, 014200, 014201, 014202, 014306, 014307, 014308, 014420, 014422, 014423, 014569, 014570, 014571, 014703 & 014805 and Material #9411-VC-006, Lot numbers: 010184, 010440, 010559, 010949, 011052, 011218, 011374, 011386 011720, 011948, 012352, 012459, 012578, 012689, 012894, 013060, 013246, 013468, 013509, 013689, 013891, 014121, 014139, 014168, 014197, 014203, 014310, 014425 & 014617.

Lot Numbers:

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Product: ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, 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 intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

Material # 9451-VC-006, Lot numbers: 010183, 010560, 010780, 010951, 010972, 011042, 011050, 011348, 011382, 011583, 011709, 011952, 012343, 012568, 012690, 013071, 013247, 013470, 013692, 013735, 013898, 014125, 014138, 014232, 014312 & 014565 and 9458-VC-006, Lot numbers: 010182, 010436, 010437, 010561, 010562, 010723, 010781, 010782, 010817, 010872, 010893, 010952, 010953, 010964, 010969, 010977, 011039, 011040, 011041, 011060, 011061, 011223, 011378, 011379, 011555, 011556, 011557, 011710, 011711, 011712, 011949, 011950, 011951, 012143, 012144, 012145, 012146, 012344, 012345, 012346, 012460, 012461, 012462, 012575, 012576, 012577, 012691, 012692, 012693, 012897, 012898, 013072, 013086, 013248, 013249, 013250, 013471, 013472, 013473, 013694, 013695, 013696, 013734, 013904, 013905, 013906, 013907, 014116, 014117, 014118, 014119, 014129, 014130, 014131, 014132, 014193, 014194, 014195, 014196, 014313, 014314, 014315, 014402, 014404, 014405, 014406, 014607, 014608 & 014609.

Lot Numbers:

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Product: ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

Material # 9461-VC-001, Lot numbers: 012579S, 013469S, 011227 & 011492; Material # 9461-VC-006, 011938, 012694, 013065, 013686 & 014615; Material # 9462-VC-001, Lot numbers: 010743S, 10778S, 010954S, 012580S & 012891S; Material # 9462-VC-006, Lot numbers: 010444, 010743, 010778, 010954, 011495, 011545, 011582, 011714, 012130, 012581, 013251, 013860, 013893, 014128 & 014316; Material # 9463-VC-001, Lot numbers: 010331S, 010955S, 011716S, 012133S & 013066S; Material # 9463-VC-006, Lot numbers: 010331, 010955, 011513, 011584, 011717, 011834, 012131, 012349, 013070, 013474, 013890, 013899, 014230, 014317 & 014616; Material # 9464-VC-001, Lot numbers: 010445S, 010744S, 010956S, 011718S, 012135S, 012695S & 013262S; Material # 9464-VC-006, Lot numbers: 010445, 010744, 010956, 011051, 011491, 011590, 011719, 011939, 012136, 012350, 012696, 012778, 013252, 013902, 014025, 014120, 014231, 014319, 014453 & 014618; Material # 9465-VC-001, Lot numbers: 010957S, 011940S & 014321S; Material # 9465-VC-006, Lot numbers: 010957, 011496, 011941, 012137, 012351, 013286, 013901 & 014322; Material # 9466-VC-001, Lot numbers: 010333S, 10844S, 010958S, 011722S & 012685S; Material # 9466-VC-006, Lot numbers: 010333, 010844, 010958, 011512, 011544, 011589, 011723, 012129, 012466, 013887, 014123, 014209 & 014323.

Lot Numbers:

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Product: OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, 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 intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

Material # 9470-VC-006, Lot numbers: 010859 & 011511.

Lot Numbers:

numbers

Product: ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, 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 intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

Material # 9471-VC-006, Lot numbers: 013107, 013260, 013889, 014126 & 014324; Material # 9472-VC-006, Lot numbers: 013108 & 013261; Material # 9403-VC-006, Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407.

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75637

Status: Resolved

Manufacturer: Teleflex Medical

Manufactured In: United States

Units Affected: 113,647 units

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers:

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Lot Numbers:

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Product: ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

Lot Numbers:

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Material # 9470-VC-006, Lot numbers: 010859 & 011511.

Lot Numbers:

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Lot Numbers:

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