Z-0930-2023 Class II Ongoing
FDA device recall Z-0930-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 18, 2022 and is designated Class II. Reason for recall: Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. The recall status is ongoing. Affected quantity: 76,053 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2023
- Initiation Date
- Nov 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76,053 units
Product 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.
Reason for Recall
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Distribution Pattern
US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0930-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026