🔍 RecallPedia

Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; g. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS; h. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR; i. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS; j. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS; k. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS. ***Expansion on 02/06/2023 with the following additional products: l. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS; m. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS; n. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS; o. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS. Indicated for use in surgical procedures where tissue separation is necessary.

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2022 MEDLINE INDUSTRIES, LP - Northfield Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    a. Item Number: CISION10CS, Box UDI/GTIN: 30193489090103, Case UDI/GTIN: 20193489090106, Lot Numbers: Y01853, Z00300, Z02246, Z02288, Z02290, Z02416, Z02246, Z02473, Z02290, Z02290, Z02290, Z02290; b. Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/GTIN: 20193489090113, Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435; c. Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/GTIN: 20193489090137, Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470; d. Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/GTIN: 20193489090151, Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584; e. Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/GTIN: 20193489090144, Lot Number: Z01076; f. Item Number: CISION15SS, Box UDI/GTIN: 30193489090202, Case UDI/GTIN: 20193489090205, Lot Numbers: Y01861, Z00320, Z02233, Z02492, Z02409, Z02409, Z02409, Z02409, Z02409, Z02482, Z00331, Z02233, Z02377, Z02377, Z02377, Z02377, Z02409, Z02409, Z02409, Z02482; g. Item Number: CISION15CS, Box UDI/GTIN: 30193489090189, Case UDI/GTIN: 20193489090182, Lot Numbers: Y01848, Y03404, Z02188, Z02611, Z02611, Z02188, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611; h. Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/GTIN: 20193489090199, Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385; i. Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/GTIN: 20193489090236, Lot Numbers: Z00343, Z02530; j. Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/GTIN: 20193489090267, Lot Numbers: Z01064, Z02417, Z02417, Z02198; k. Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/GTIN: 20193489090281, Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355. ***Expansion on 02/06/2023 with the following additional products: l. Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/GTIN: 20193489090175, Lot Number: Z01277; m. Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/GTIN: 20193489090212, Lot Numbers: Z01206, Z02485, Z02550; n. Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/GTIN: 20193489090243, Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658; o. Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/GTIN: 20193489090250, Lot Number: Z00312.
  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:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; g. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS; h. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR; i. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS; j. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS; k. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS. ***Expansion on 02/06/2023 with the following additional products: l. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS; m. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS; n. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS; o. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS. Indicated for use in surgical procedures where tissue separation is necessary.

Product Codes/Lot Numbers:

a. Item Number: CISION10CS, Box UDI/GTIN: 30193489090103, Case UDI/GTIN: 20193489090106, Lot Numbers: Y01853, Z00300, Z02246, Z02288, Z02290, Z02416, Z02246, Z02473, Z02290, Z02290, Z02290, Z02290; b. Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/GTIN: 20193489090113, Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435; c. Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/GTIN: 20193489090137, Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470; d. Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/GTIN: 20193489090151, Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584; e. Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/GTIN: 20193489090144, Lot Number: Z01076; f. Item Number: CISION15SS, Box UDI/GTIN: 30193489090202, Case UDI/GTIN: 20193489090205, Lot Numbers: Y01861, Z00320, Z02233, Z02492, Z02409, Z02409, Z02409, Z02409, Z02409, Z02482, Z00331, Z02233, Z02377, Z02377, Z02377, Z02377, Z02409, Z02409, Z02409, Z02482; g. Item Number: CISION15CS, Box UDI/GTIN: 30193489090189, Case UDI/GTIN: 20193489090182, Lot Numbers: Y01848, Y03404, Z02188, Z02611, Z02611, Z02188, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611; h. Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/GTIN: 20193489090199, Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385; i. Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/GTIN: 20193489090236, Lot Numbers: Z00343, Z02530; j. Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/GTIN: 20193489090267, Lot Numbers: Z01064, Z02417, Z02417, Z02198; k. Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/GTIN: 20193489090281, Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355. ***Expansion on 02/06/2023 with the following additional products: l. Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/GTIN: 20193489090175, Lot Number: Z01277; m. Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/GTIN: 20193489090212, Lot Numbers: Z01206, Z02485, Z02550; n. Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/GTIN: 20193489090243, Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658; o. Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/GTIN: 20193489090250, Lot Number: Z00312.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0930-2023

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