Z-0930-2023Class II

Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10...

Name: Z-0930-2023 Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-11-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-18 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE... on 2022-11-18. FDA classified it as Class II and gives the reason as "Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0930-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2023-01-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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 code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline notified customers on about 11/18/2022, via letter. Customers were instructed to immediately check stock for the affected item number and the affected lot numbers, and to destroy all affected product. Customers were also instructed to notify customers if the product was further distributed and to complete a response form. On 02/06/2023, the recall was expanded to include additional item numbers and consignees were notified.
Quantity in commerce: 76,053 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)