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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Teleflex Medical
Reason for Recall:
Sterility: Due to a potential incomplete seal on the outer sterile package.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0676-2017

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