Class II Recall

Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/

Summary

The FDA issued a Class II for Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS50 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u.

Details

Source

Device Recall

External ID

Z-1444-2024

Action Date

2024-04-10

Status

Ongoing

Product Description

Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350; i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365; j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450; k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465; l) STERILE CURV MAYO SCISSOR 5 1/2" (81310), Product Code 66665; m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710; n) STERILE 6 1/2" S/B SCISSOR (11109SB), Product Code 66820; o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845; p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885; q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890; r) STERILE CURVED METZENBAUM (ST142), Product Code 66895; s) STERILE B/B SCISSOR 6 1/2", Product Code 66995; t) STERILE 6 3/4" MAYO SCISSOR, Product Code 67160; u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165; v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185; w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450; x) STERILE 51/2" EPISIOTOMY SCISSOR (11140), Product Code 67645; y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650; z) STERILE REPROCESSED 6 1/2" S/B SCISSOR, Product Code 66820K; aa) ST METZENBAUM SCISSOR CURVED 9"(MBS90C), Product Code I68510; bb) ST UMBILICAL SCISSOR, CRVD, 4" (11148), Product Code I68575; cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790; dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600; ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K; ff) STERILE STR MAYO SCISSOR 5 1/2" (ST115), Product Code TRI67630 MEDLINE: MEDLINE manual surgical kits labeled as: a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000; b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133

Lot/Code Info: a) 65145, UDI/DI 60653160023758 (case) 00653160023756 (each), Lot Numbers: 2023071990, 2023100390; b) 65940, UDI/DI 70653160018805 (case) 00653160018806 (each), Lot Numbers: 2023112290; c) 65945, UDI/DI 60653160024823 (case) 00653160024821 (each), Lot Numbers: 2023041290, 2023042890, 2023050190, 2023051890, 2023051990, 2023052290, 2023052490, 2023052590, 2023062090, 2023071490, 2023071790, 2023090290, 2023110190; d) 66150, UDI/DI 60653160023765 (case) 00653160023763 (each), Lot Numbers: 2023041390, 2023071490, 2023091890, 2023101190; e) 66155, UDI/DI 70653160022970 (case) 00653160022971 (each), Lot Numbers: 2023030390, 2023032990, 2023033090, 2023041890, 2023071090; f) 66215, UDI/DI 60653160004863 (case) 00653160004861 (each), Lot Numbers: 2023052690, 2023102790; g) 66260, UDI/DI 60653160008366 (case) 00653160008364 (each), Lot Numbers: 2023022290; h) 66350, UDI/DI 50653160018306 (case) 00653160018301 (each), Lot Numbers: 2023062790, 2023091190; i) 66365, UDI/DI 10653160025672 (case) 00653160025675 (each), Lot Numbers: 2023041990, 2023072890; j) 66450, UDI/DI 60653160022348 (case) 00653160022346 (each), Lot Numbers: 2023022890, 2023030190; k) 66465, UDI/DI 10653160023067 (case) 00653160023060 (each), Lot Numbers: 2023063090; l) 66665, UDI/DI 60653160082717 (case) 00653160082715 (each), Lot Numbers: 2023061490, 2023071990, 2023100690; m) 66710, UDI/DI 70653160046341 (case) 00653160046342 (each), Lot Numbers: 2023111090; n) 66820, UDI/DI 60653160028289 (case) 00653160028287 (each), Lot Numbers: 2023061490, 2023101890; o) 66845, UDI/DI 60653160048058 (case) 00653160048056 (each), Lot Numbers: 2023090190; p) 66885, UDI/DI 50653160049256 (case) 00653160049251 (each), Lot Numbers: 2023030990; q) 66890, UDI/DI 60653160049246 (case) 00653160049244 (each), Lot Numbers: 2023040690, 2023041090, 2023100990; r) 66895, UDI/DI 50653160006563 (case) 00653160006568 (each), Lot Numbers: 2023102690; s) 66995, UDI/DI 60653160048393 (case) 00653160048391 (each), Lot Numbers: 2023032390, 2023110390; t) 67160, UDI/DI 50653160052195 (case) 00653160052190 (each), Lot Numbers: 2023032790; u) 67165, UDI/DI 60653160046962 (case) 00653160046960 (each), Lot Numbers: 2023030390; v) 67185, UDI/DI 60653160038745 (case) 00653160038743 (each), Lot Numbers: 2023042590, 2023112290; w) 67450, UDI/DI 30653160134989 (case) 00653160134988 (each), Lot Numbers: 2023100690; x) 67645, UDI/DI 30653160195850 (case) 00653160195859 (each), Lot Numbers: 2023021490, 2023060790, 2023112790; y) 67650, UDI/DI 30653160195867 (case) 00653160195866 (each), Lot Numbers: 2023030390; z) 66820K, UDI/DI 00653160351408 (case) 10653160351405 (each), Lot Numbers: 2023050890 (not distributed) aa) I68510, UDI/DI 00653160293074 (case) 10653160293071 (each), Lot Numbers: 2023031390, 2023091890; bb) I68575, UDI/DI 00653160306675 (case) 10653160306672 (each), Lot Numbers: 2023022290, 2023041190, 2023060790; cc) I68790, UDI/DI 00653160327656 (case) 10653160327653 (each), Lot Numbers: 2023101890, 2023111690; dd) TRI66600, UDI/DI 00653160317992 (case) 10653160317999 (each), Lot Numbers: 2023021490, 2023041190; ee) TRI66670K, UDI/DI 00653160358667 (case) 10653160358664 (each), Lot Numbers: 2023030990, 2023040690; ff) TRI67630, UDI/DI 00653160317923 (case) 10653160317920 (each), Lot Numbers: 2023100690, 2023112790; MEDLINE: a) DYND04000, UDI/DI 20193489191346 (case) 10193489191349 (each), Lot Numbers: 2023021490, 2023050390, 2023050590, 2023050790, 2023051090, 2023050690, 2023050890, 2023050990, 2023051190, 2023051290, 2023051390, 2023051690, 2023050490, 2023051890, 2023051990, 2023052090, 2023052290, 2023052390, 2023052590, 2023052690, 2023052790, 2023052990, 2023053090, 2023060190, 2023060490, 2023060790, 2023060990, 2023061090, 2023061390, 2023061490, 2023061590, 2023070690, 2023081790, 2023081890, 2023101690, 2023102490, 2023102590, 2023102790, 2023102890, 2023102690, 2023112290, 2023112390, 2023110790; b) DYND04133, UDI/DI 20193489191360 (case) 10193489191363 (each), Lot Numbers: 2023033190, 2023101890

Quantity Affected: 568,849 units

Reason for Recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-23

Company

MEDLINE INDUSTRIES, LP - Northfield

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 200 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1444-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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