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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94581

27 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

27 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 27

Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G

Z-2739-2024
Recall number
Z-2739-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJAA0327F , Lot Number 20LBV329 ; DYNJAA0327G , Lot Number 21FBM358 ; DYNJAA0327G , Lot Number 22CBY412 ; DYNJAA0327G , Lot Number 22GBZ157 ; DYNJAA0327G , Lot Number 22JBR268 ; DYNJAA0327G , Lot Number 23BBL309 ; DYNJAA0327G , Lot Number 23HBU238 ; DYNJAA0327G , Lot Number 23KBB605 ; DYNJAA0327G , Lot Number 24CBJ211 ;

Distribution pattern

Worldwide

device · product 2 of 27

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

Z-2740-2024
Recall number
Z-2740-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598

Distribution pattern

Worldwide

device · product 3 of 27

Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H

Z-2741-2024
Recall number
Z-2741-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJRA2040H, Lot Number 23CBH893; DYNJRA2040H, Lot Number 23HBX547; DYNJRA2040H, Lot Number 23JBN538; DYNJRA2040H, Lot Number 24ABQ696; DYNJRA2040H, Lot Number 24CBG746

Distribution pattern

Worldwide

device · product 4 of 27

Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095

Z-2742-2024
Recall number
Z-2742-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

1) MNS9865 , Lot Number 2021111050; 2) CIT6715 , Lot Number 2023050590; 3) CIT7095 , Lot Number 2023091990;

Distribution pattern

Worldwide

device · product 5 of 27

Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P; 8) OPEN HEART A&B PACK, Pack Number CMPJ02162I; 9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J; 10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C; 11) VASCULAR PACK, Pack Number CMPJ08949F; 12) BOISE HEART PACK-LF, Pack Number CMPJ09225F; 13) VASCULAR PACK, Pack Number CMPJ09236D; 14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F; 15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C; 16) CAROTID PACK, Pack Number CMPJ10797B; 17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A; 18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B; 19) VASCULAR PACK, Pack Number CMPJ13632; 20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M; 21) CABG PACK-LF, Pack Number DYNJ0824648K; 22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R; 23) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 24) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G; 26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F; 27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G; 28) EP PACER PACK, Pack Number DYNJ38863N; 29) EP PACER PACK, Pack Number DYNJ38863O; 30) PERFUSION SYRINGE, Pack Number DYNJ39223C; 31) VASCULAR PACK, Pack Number DYNJ39525; 32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C; 33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D; 34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A; 35) HEART VALVE PACK, Pack Number DYNJ58365J; 36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A; 37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A; 38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A; 39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B; 40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C; 41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A; 42) VASCULAR PACK, Pack Number DYNJ63182A; 43) VASCULAR SHARED, Pack Number DYNJ64801B; 44) VASCULAR PACK, Pack Number DYNJ65160; 45) VASCULAR DSC, Pack Number DYNJ69172B; 46) OPEN HEART PACK, Pack Number DYNJ83695; 47) WMC HYBRID OR, Pack Number DYNJ904036J; 48) VASCULAR, Pack Number DYNJ904845G; 49) BOISE HEART, Pack Number DYNJ905070I; 50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F; 51) VASCULAR PACK, Pack Number DYNJ905226D; 52) CAROTID, Pack Number DYNJ906561F; 53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A; 54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B; 55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B; 56) KIT OPEN HEART, Pack Number DYNJ908603B; 57) VASCULAR PACK, Pack Number DYNJ909374; 58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768; 59) ADULT CORONARY PACK, Pack Number DYNJV0275J; 60) ADULT CORONARY PACK, Pack Number DYNJV0275K; 61) ADULT CORONARY PACK, Pack Number DYNJV0275M; 62) ADULT CORONARY PACK, Pack Number DYNJV0275N

Z-2743-2024
Recall number
Z-2743-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS981050Q , Lot Numbers : 23IBJ172 ; CDS982411N , Lot Numbers : 23IBH624 ; CDS982411N , Lot Numbers : 23IBI963 ; CDS983348AA, Lot Numbers : 23FBN637 ; CDS983348AA, Lot Numbers : 24ABM288 ; CDS983348AA, Lot Numbers : 24ABR888 ; CDS983348X , Lot Numbers : 22GBA977 ; CDS983348X , Lot Numbers : 22KBB264 ; CDS983348Y , Lot Numbers : 23BBR849 ; CDS983348Y , Lot Numbers : 23CBM949 ; CDS983348Y , Lot Numbers : 23DBB694 ; CDS984206R , Lot Numbers : 22GBP993 ; CDS984206R , Lot Numbers : 22HBU408 ; CDS984206R , Lot Numbers : 22KLA374 ; CDS984206R , Lot Numbers : 22KLB170 ; CDS984206R , Lot Numbers : 22LLA600 ; CDS984206R , Lot Numbers : 23ALA250 ; CDS984206R , Lot Numbers : 23ALA462 ; CDS984206R , Lot Numbers : 23ALA777 ; CDS984206R , Lot Numbers : 23BLA402 ; CMPJ01037P , Lot Numbers : 23HBT114 ; CMPJ02162I , Lot Numbers : 23HBT075 ; CMPJ03510J , Lot Numbers : 22GBD932 ; CMPJ03510J , Lot Numbers : 22GBK674 ; CMPJ03510J , Lot Numbers : 22JLA999 ; CMPJ03510J , Lot Numbers : 22KLA443 ; CMPJ03510J , Lot Numbers : 22LLA230 ; CMPJ03510J , Lot Numbers : 22LLA577 ; CMPJ03510J , Lot Numbers : 23ALA797 ; CMPJ06631C , Lot Numbers : 23HBQ375 ; CMPJ06631C , Lot Numbers : 23HBU697 ; CMPJ08949F , Lot Numbers : 23HBT997 ; CMPJ09225F , Lot Numbers : 23HBP652 ; CMPJ09236D , Lot Numbers : 22GBG807 ; CMPJ09236F , Lot Numbers : 22HBN769 ; CMPJ09236F , Lot Numbers : 22HBY712 ; CMPJ09236F , Lot Numbers : 23FBF790 ; CMPJ09236F , Lot Numbers : 23FBM695 ; CMPJ09400C , Lot Numbers : 23HBZ030 ; CMPJ10797B , Lot Numbers : 23JMD630 ; CMPJ10797B , Lot Numbers : 23KMC572 ; CMPJ10985A , Lot Numbers : 22FBL206 ; CMPJ10985A , Lot Numbers : 22GBI791 ; CMPJ10985B , Lot Numbers : 23FBK179 ; CMPJ10985B , Lot Numbers : 23GBV588 ; CMPJ10985B , Lot Numbers : 23HBM747 ; CMPJ10985B , Lot Numbers : 23LBA858 ; CMPJ13632, Lot Numbers : 23BMH813 ; CMPJ13632, Lot Numbers : 23GMC952 ; DYNJ0382048M , Lot Numbers : 23IBB114 ; DYNJ0824648K , Lot Numbers : 24AMF586 ; DYNJ16541R , Lot Numbers : 21HMA102 ; DYNJ16541R , Lot Numbers : 21IMA181 ; DYNJ35495G , Lot Numbers : 21EMF046 ; DYNJ35495G , Lot Numbers : 22AMD743 ; DYNJ35495G , Lot Numbers : 22EMD093 ; DYNJ35495G , Lot Numbers : 22FMF078 ; DYNJ35495G , Lot Numbers : 22GMC660 ; DYNJ35495G , Lot Numbers : 22HMF027 ; DYNJ35495G , Lot Numbers : 22IMC912 ; DYNJ35495G , Lot Numbers : 22JMA533 ; DYNJ35495G , Lot Numbers : 22JMD015 ; DYNJ35495G , Lot Numbers : 23DMH903 ; DYNJ35495G , Lot Numbers : 23EME329 ; DYNJ35495G , Lot Numbers : 24AMF976 ; DYNJ35495G , Lot Numbers : 24CME720 ; DYNJ35578G , Lot Numbers : 21IMA037 ; DYNJ35578G , Lot Numbers : 22HMA397 ; DYNJ35578G , Lot Numbers : 22IMF130 ; DYNJ35578G , Lot Numbers : 22JMA828 ; DYNJ38318F , Lot Numbers : 21GME196 ; DYNJ38318F , Lot Numbers : 22CME760 ; DYNJ38318F , Lot Numbers : 22DMD733 ; DYNJ38318G , Lot Numbers : 23CMH527 ; DYNJ38318G , Lot Numbers : 23FMI730 ; DYNJ38318G , Lot Numbers : 23GMH025 ; DYNJ38318G , Lot Numbers : 23KMF993 ; DYNJ38863N , Lot Numbers : 21JBD563 ; DYNJ38863N , Lot Numbers : 21KBU816 ; DYNJ38863N , Lot Numbers : 22GBL827 ; DYNJ38863N , Lot Numbers : 22HBO261 ; DYNJ38863O , Lot Numbers : 22JBX664 ; DYNJ38863O , Lot Numbers : 23JBU100 ; DYNJ39223C , Lot Numbers : 23JMH881 ; DYNJ39525, Lot Numbers : 23HBO406 ; DYNJ44420C , Lot Numbers : 21DMB030 ; DYNJ44420C , Lot Numbers : 21IMG926 ; DYNJ44420C , Lot Numbers : 22AMB411 ; DYNJ44420C , Lot Numbers : 23FMA481 ; DYNJ44420C , Lot Numbers : 23KME889 ; DYNJ44565D , Lot Numbers : 23IBD702 ; DYNJ56510A , Lot Numbers : 23IBE173 ; DYNJ58365J , Lot Numbers : 22BMF809 ; DYNJ58365J , Lot Numbers : 22CMA087 ; DYNJ58365J , Lot Numbers : 22CMF024 ; DYNJ58365J , Lot Numbers : 22DME619 ; DYNJ58365J , Lot Numbers : 22KMF019 ; DYNJ58365J , Lot Numbers : 22LMA757 ; DYNJ58365J , Lot Numbers : 23AMI644 ; DYNJ58873A , Lot Numbers : 23HBO872 ; DYNJ60177A , Lot Numbers : 22GBZ669 ; DYNJ60904A , Lot Numbers : 23CBL795 ; DYNJ60904A , Lot Numbers : 23DBQ189 ; DYNJ60904A , Lot Numbers : 23GBG492 ; DYNJ60904A , Lot Numbers : 21CMD975 ; DYNJ60904A , Lot Numbers : 21FMC958 ; DYNJ60904A , Lot Numbers : 21HME949 ; DYNJ60904A , Lot Numbers : 21LMG891 ; DYNJ60904B , Lot Numbers : 23IBR916 ; DYNJ60904B , Lot Numbers : 23JBO985 ; DYNJ60904C , Lot Numbers : 24BBT698 ; DYNJ60904C , Lot Numbers : 24CBD151 ; DYNJ61603A , Lot Numbers : 23IDB820 ; DYNJ63182A , Lot Numbers : 23IBB016 ; DYNJ64801B , Lot Numbers : 23JDA487 ; DYNJ65160, Lot Numbers : 21GDC784 ; DYNJ65160, Lot Numbers : 21HDA957 ; DYNJ65160, Lot Numbers : 21HDC449 ; DYNJ65160, Lot Numbers : 22CDA586 ; DYNJ65160, Lot Numbers : 22CDB328 ; DYNJ65160, Lot Numbers : 23HDA374 ; DYNJ69172B , Lot Numbers : 23KMC637 ; DYNJ83695, Lot Numbers : 23KMC043 ; DYNJ904036J, Lot Numbers : 23GBO515Z; DYNJ904845G, Lot Numbers : 23IBO715 ; DYNJ905070I, Lot Numbers : 23IBL120 ; DYNJ905079F, Lot Numbers : 22IBS192 ; DYNJ905079F, Lot Numbers : 23GBV464 ; DYNJ905226D, Lot Numbers : 23IBT451 ; DYNJ906561F, Lot Numbers : 23KMD566 ; DYNJ906561F, Lot Numbers : 23LMC047 ; DYNJ906744A, Lot Numbers : 22HBA285 ; DYNJ906744A, Lot Numbers : 22HBS673 ; DYNJ906744A, Lot Numbers : 22JBC173 ; DYNJ906744B, Lot Numbers : 23GBB637 ; DYNJ906744B, Lot Numbers : 23HBL689 ; DYNJ906744B, Lot Numbers : 23LBJ453 ; DYNJ907201B, Lot Numbers : 23IBQ651 ; DYNJ907201B, Lot Numbers : 23IBR482 ; DYNJ908603B, Lot Numbers : 23DLA943 ; DYNJ908603B, Lot Numbers : 23ELA182 ; DYNJ908603B, Lot Numbers : 23ILA483 ; DYNJ908603B, Lot Numbers : 23JLA399 ; DYNJ908603B, Lot Numbers : 23JLA761 ; DYNJ908603B, Lot Numbers : 23LLA530 ; DYNJ908603B, Lot Numbers : 24ALA353 ; DYNJ909374 , Lot Numbers : 23CMF350 ; DYNJ909374 , Lot Numbers : 23GMH651 ; DYNJ909768 , Lot Numbers : 23KDA010 ; DYNJ909768 , Lot Numbers : 23KDB476 ; DYNJV0275J , Lot Numbers : 20JMD542 ; DYNJV0275K , Lot Numbers : 21FMB371 ; DYNJV0275M , Lot Numbers : 22BMG807 ; DYNJV0275M , Lot Numbers : 22CMD978 ; DYNJV0275M , Lot Numbers : 22DMB068 ; DYNJV0275M , Lot Numbers : 22DME051 ; DYNJV0275M , Lot Numbers : 22DMH576 ; DYNJV0275M , Lot Numbers : 22EME738 ; DYNJV0275M , Lot Numbers : 22GMB674 ; DYNJV0275M , Lot Numbers : 22KMA130 ; DYNJV0275N , Lot Numbers : 23JMH200 ; DYNJV0275N , Lot Numbers : 23LMA628

Distribution pattern

Worldwide

device · product 6 of 27

Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

Z-2744-2024
Recall number
Z-2744-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CIT6780, Lot Number 2022072650; CIT6920, Lot Number 2023101290

Distribution pattern

Worldwide

device · product 7 of 27

Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825

Z-2745-2024
Recall number
Z-2745-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ85516, Lot Number 23JBI659 ; DYNJ85516, Lot Number 23LBE170 ; DYNJ85516, Lot Number 23LBR472 ; PICCNC0004 , Lot Number 23JMG079 ; CVI4825, Lot Number 22FLA595 ; CVI4825, Lot Number 22JLA721 ; CVI4825, Lot Number 22JLB203 ; CVI4825, Lot Number 22KLA852

Distribution pattern

Worldwide

device · product 8 of 27

Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A

Z-2746-2024
Recall number
Z-2746-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

1) DYNJ63370A , Lot Number 23IMB164 ; 2) CIT7210, Lot Number 2022101890; 3) DYNDA2271, Lot Number 2023090790; 4) CIT6780, Lot Number 2022101890; 5) DYNDH1512A, Lot Number 2023090790

Distribution pattern

Worldwide

device · product 9 of 27

Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941

Z-2747-2024
Recall number
Z-2747-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165; CDS982016T, Lot Numbers:22HBS644; CMPJ01846O, Lot Numbers:21LBQ988; CMPJ01846O, Lot Numbers:22FBV101; CMPJ05884J, Lot Numbers:21KBO037; CMPJ05884J, Lot Numbers:21KBU691; CMPJ05884J, Lot Numbers:21LBH778; CMPJ05884J, Lot Numbers:22IBG052; CMPJ05884J, Lot Numbers:22JBN865; CMPJ09860D, Lot Numbers:23KMB793; CMPJ09914C, Lot Numbers:23IDA209; CMPJ13389A, Lot Numbers:23CBL552; CMPJ13389B, Lot Numbers:23IBC818; CMPJ13389C, Lot Numbers:23KBU012; CMPJ13389C, Lot Numbers:23LBF106; CMPJ13389C, Lot Numbers:24ABD504; CMPJ13389C, Lot Numbers:24ABY610; CMPJ13389C, Lot Numbers:24BBV889; CMPJ13509, Lot Numbers:23IBF142; CMPJ21114O, Lot Numbers:23BBQ474; CMPJ21114O, Lot Numbers:23HBG033; CMPJ21114O, Lot Numbers:23IBV766; CMPJ21114O, Lot Numbers:23JBM292; CMPJ21114O, Lot Numbers:23KBK531; CMPJ21114O, Lot Numbers:21BBJ985; DYNJ0425965G, Lot Numbers:23GMH984; DYNJ0774664K, Lot Numbers:23HBP871; DYNJ40560B, Lot Numbers:23HBF219; DYNJ40560BH , Lot Numbers:23HBF219; DYNJ44134C, Lot Numbers:22JBQ075; DYNJ44134D, Lot Numbers:23BBK410; DYNJ44134D, Lot Numbers:23CBS145; DYNJ44134F, Lot Numbers:23EBC602; DYNJ44134F, Lot Numbers:23GBV482; DYNJ44134F, Lot Numbers:23JBP398; DYNJ44134F, Lot Numbers:23KBN024; DYNJ44134F, Lot Numbers:24ABC027; DYNJ45577A, Lot Numbers:21KBL221; DYNJ45577A, Lot Numbers:21KBT524; DYNJ48595, Lot Numbers:24BBO457; DYNJ49888I, Lot Numbers:22AMG372; DYNJ49888I, Lot Numbers:22KMD386; DYNJ49888J, Lot Numbers:24AMG698; DYNJ52583G, Lot Numbers:21HBC324; DYNJ52583G, Lot Numbers:21KBM269; DYNJ52583J, Lot Numbers:21LBN305; DYNJ52583L, Lot Numbers:22DBB163; DYNJ52583L, Lot Numbers:22FBF207; DYNJ52583L, Lot Numbers:22HMF439; DYNJ52583L, Lot Numbers:22JMC614; DYNJ52583L, Lot Numbers:23JMF994; DYNJ52583M, Lot Numbers:24CMF962; DYNJ57200A, Lot Numbers:23HBN488; DYNJ65935A, Lot Numbers:23HBR355; DYNJ65935A, Lot Numbers:23HBT376; DYNJ66039B, Lot Numbers:23GBQ016; DYNJ82177B, Lot Numbers:23KMB826; DYNJ82177BH , Lot Numbers:23KMB826; DYNJ82564, Lot Numbers:23GBV431; DYNJ86113, Lot Numbers:24CBE092; DYNJ901779J , Lot Numbers:21KBY716; DYNJ901779J , Lot Numbers:21LBS995; DYNJ901779J , Lot Numbers:21LBV102; DYNJ901779J , Lot Numbers:22IBS613; DYNJ901779J , Lot Numbers:22JBY312; DYNJ901779J , Lot Numbers:22JBY313; DYNJ901779J , Lot Numbers:23BBB017; DYNJ905642D , Lot Numbers:23KMH482; DYNJ905694C , Lot Numbers:23IDB849; DYNJ909128A , Lot Numbers:23DBD851; DYNJ909128C , Lot Numbers:23JBO251; DYNJ909128D , Lot Numbers:23LBM416; DYNJ909128D , Lot Numbers:23LBQ695; DYNJ909128D , Lot Numbers:24ABR742; DYNJ909128D , Lot Numbers:24BBM816; DYNJ909128D , Lot Numbers:24CBK211; DYNJ909251, Lot Numbers:23IBT842; DYNJ909251, Lot Numbers:23IBT854; DYNJ909251, Lot Numbers:23IBV449; DYNJ909251, Lot Numbers:23JBT806; DYNJ909941, Lot Numbers:23JBH984; DYNJ909941, Lot Numbers:24ABD605; DYNJ909941, Lot Numbers:24ABD695; DYNJ909941, Lot Numbers:24ABT569; DYNJ909941, Lot Numbers:24CBK472

Distribution pattern

Worldwide

device · product 10 of 27

Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O

Z-2748-2024
Recall number
Z-2748-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CMPJ26754O, Lot Number 23HBE567; CDS840214Q, Lot Number 23IBC884

Distribution pattern

Worldwide

device · product 11 of 27

Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271

Z-2749-2024
Recall number
Z-2749-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA2271, Lot Number 2022111490

Distribution pattern

Worldwide

device · product 12 of 27

Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS PACK-LF , Pack Number DYNJ0608555P; 7) OCCULAR PLASTIC, Pack Number DYNJ901206F; 8) OCCULAR PLASTIC PACK, Pack Number CMPJ05506F; 9) OCCULOPLASTIC PACK, Pack Number DYNJ65156; 10) PLASTIC PACK, Pack Number DYNJ47842C;

Z-2750-2024
Recall number
Z-2750-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKM2000 , Lot Number: 21FBO406 DYKM2000 , Lot Number: 22DBI980 DYKM2000 , Lot Number: 22KBD028 DYKM2000 , Lot Number: 23JBC148 DYKM2000 , Lot Number: 24ABL480 DYKM2000 , Lot Number: 21ABM981 DYKM2000 , Lot Number: 21BBR866 DYNJ902703K, Lot Number: 21FBI191 DYNJ902703K, Lot Number: 21FBR340 DYNJ902703K, Lot Number: 22OBL867 DYNJ902703K, Lot Number: 22DBH342 DYNJ902703K, Lot Number: 22DBI420 DYNJ902703K, Lot Number: 22FBM439 DYNJ38988J , Lot Number: 23JDA299 DYNJ82179A , Lot Number: 23JDB728 DYNJ82179AH, Lot Number: 23JDB728 DYNJ0608555P , Lot Number: 23GMI735 DYNJ0608555P , Lot Number: 23KMC310 DYNJ901206F, Lot Number: 23IBC085 DYNJ901206F, Lot Number: 23LBA443 DYNJ901206F, Lot Number: 24ABY049 CMPJ05506F , Lot Number: 23HBM696 CMPJ05506F , Lot Number: 23KBK942 CMPJ05506F , Lot Number: 24ABM251 DYNJ65156, Lot Number: 21GDC910 DYNJ65156, Lot Number: 21JDA096 DYNJ65156, Lot Number: 22CDC307 DYNJ65156, Lot Number: 23BDC115 DYNJ65156, Lot Number: 23EDC523 DYNJ65156, Lot Number: 23GDA856 DYNJ47842C , Lot Number: 23HBV422

Distribution pattern

Worldwide

device · product 13 of 27

Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number ACC010641 ; 6) NEONATAL DRAWER 6 , Pack Number ACC010653 ; 7) DRAWER 2, Pack Number ACC010690 ; 8) ****, Pack Number ACC010690 ; 9) DRAWER 3, Pack Number ACC010784 ; 10) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 11) CIRCUMCISION KIT, Pack Number CIT6535; 12) CIRCUMCISION TRAY, Pack Number CIT6720; 13) CIRCUMCISION TRAY, Pack Number CIT6720A; 14) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 17) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 18) RETINA LAC/USC PACK , Pack Number CMPJ03205D; 19) AAA PACK-LF, Pack Number CMPJ09869B; 20) ****, Pack Number CMPJ21114P; 21) BRONCHOSCOPY KIT, Pack Number DYKE1764; 22) TRUNK KIT W/OUT EXPIRATION, Pack Number DYKM1360A ; 23) PRE OP KIT, Pack Number DYKS1256B ; 24) CIRCUMCISION TRAY, Pack Number DYNDA2271; 25) DMEK KIT, Pack Number DYNDA3103 ; 26) KIT, NICU - PICU , Pack Number DYNDL1576 ; 27) BASIC EYE PACK-LF , Pack Number DYNJ0413783N ; 28) VASCULAR PACK, Pack Number DYNJ34240I; 29) VASCULAR PACK-LF, Pack Number DYNJ52214 ; 30) SONDHEIMER, Pack Number DYNJ53853C; 31) BUCKLE PACK, Pack Number DYNJ57439A; 32) RETINA CUSTOM PACK, Pack Number DYNJ57970A; 33) AESC PHACO PACK, Pack Number DYNJ58135C; 34) PED RIGHT LEFT HEART PK MHS , Pack Number DYNJ58874 ; 35) PEDIATRIC RIGHT HEART PK MHS, Pack Number DYNJ58875 ; 36) CV MAJOR, Pack Number DYNJ64530 ; 37) ORL BRONCHOSCOPY PACK, Pack Number DYNJ80103A; 38) ISLET CELL , Pack Number DYNJ80490 ; 39) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179 ; 40) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179H; 41) ACCESSORY KIT, Pack Number DYNJ901348D; 42) AAA, Pack Number DYNJ905651B; 43) PROCEDURE TRAY , Pack Number DYNJRA0345F; 44) PROCEDURE TRAY , Pack Number DYNJRA1250B; 45) PROCEDURE TRAY , Pack Number DYNJRA1777; 46) BLOCK TRAY, Pack Number DYNJRA2352; 47) ADULT CORONARY PACK , Pack Number DYNJV0275O; 48) ****, Pack Number DYNJV0275O; 49) NURSING KIT, Pack Number EDUC05026 ; 50) RNSG 2308 , Pack Number EDUC1031; 51) RNSG 2308 , Pack Number EDUC1031H ; 52) RNSG 2201 , Pack Number EDUC1034; 53) RNSG 2201 , Pack Number EDUC1034H ; 54) RETINAL INJECTION KIT, Pack Number MNS12465; 55) ARTHROGRAPH TRAY, Pack Number MNS12670A; 56) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 57) PERIPHERAL ULTRASOUND CATHETER, Pack Number MNS9865 ; 58) UVT KIT , Pack Number PAIN1396; 59) SHUNT PACK-LF, Pack Number PHS967363W; 60) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 61) GLMI ARTHROGRAM KIT , Pack Number SPEC0300B ; 62) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190B; 63) UMBILICAL TRAY , Pack Number UVT1195 ; 64) UVT KIT , Pack Number UVT1200 ; 65) UVT KIT , Pack Number UVT1200H; 66) UMBILICAL CATH KIT, Pack Number UVT1210 ; 67) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT150; 68) UMBILICAL VESSEL CATHETER TRAY, Pack Number UVT665A ; 69) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT915

Z-2751-2024
Recall number
Z-2751-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

ACC010417, Lot Numbers: 21JDC136; ACC010417, Lot Numbers: 21LDA261; ACC010417, Lot Numbers: 22BDA205; ACC010417, Lot Numbers: 22FDB645; ACC010417A , Lot Numbers: 23GDA903; ACC010417A , Lot Numbers: 23HDA001; ACC010417A , Lot Numbers: 23HDB495; ACC010417A , Lot Numbers: 23IDA233; ACC010417A , Lot Numbers: 23IDB522; ACC010417A , Lot Numbers: 23JDB187; ACC010427A , Lot Numbers: 23EDA979; ACC010427A , Lot Numbers: 23IDB947; ACC010605, Lot Numbers: 22LDB120; ACC010605, Lot Numbers: 23ADB200; ACC010605, Lot Numbers: 23ADB656; ACC010605, Lot Numbers: 23BDA934; ACC010641, Lot Numbers: 23GDC055; ACC010653, Lot Numbers: 23HDC266; ACC010690, Lot Numbers: 23IDA111; ACC010690, Lot Numbers: 23IDB053; ACC010690, Lot Numbers: 24CDB296; ACC010784, Lot Numbers: 24CDA251; CIT4845, Lot Numbers: 2022070190; CIT6535, Lot Numbers: 2023122680; CIT6720, Lot Numbers: 2022050290; CIT6720, Lot Numbers: 2023052690; CIT6720A, Lot Numbers: 2023111090; CIT6780, Lot Numbers: 2023052690; CIT6920, Lot Numbers: 2022030890; CIT6925, Lot Numbers: 2022051690; CIT6925, Lot Numbers: 2022101090; CIT6925, Lot Numbers: 2023062690; CIT7095, Lot Numbers: 2022071390; CMPJ03205D , Lot Numbers: 24BBI377; CMPJ09869B , Lot Numbers: 23HMH649; CMPJ09869B , Lot Numbers: 23KMB759; CMPJ09869B , Lot Numbers: 24AME944; CMPJ21114P , Lot Numbers: 24CBJ402; DYKE1764 , Lot Numbers: 22FBS049; DYKE1764 , Lot Numbers: 23ABO112; DYKE1764 , Lot Numbers: 23CBR915; DYKE1764 , Lot Numbers: 23IBF012; DYKM1360A, Lot Numbers: 23FBT211; DYKS1256B, Lot Numbers: 21CBR391; DYKS1256B, Lot Numbers: 21DBV160; DYKS1256B, Lot Numbers: 21HMG454; DYKS1256B, Lot Numbers: 22AMG240; DYKS1256B, Lot Numbers: 22DMF530; DYKS1256B, Lot Numbers: 23CMD114; DYKS1256B, Lot Numbers: 23GMA886; DYKS1256B, Lot Numbers: 23HMH613; DYNDA2271, Lot Numbers: 2022070190; DYNDA3103, Lot Numbers: 24BBA889; DYNDL1576, Lot Numbers: 23DBF325; DYNDL1576, Lot Numbers: 23FBF144; DYNDL1576, Lot Numbers: 24ABO204; DYNDL1576, Lot Numbers: 24BBO954; DYNJ0413783N, Lot Numbers: 23IMC236; DYNJ0413783N, Lot Numbers: 23JMB485; DYNJ34240I , Lot Numbers: 21KBQ916; DYNJ34240I , Lot Numbers: 21KBQ921; DYNJ34240I , Lot Numbers: 22FBJ330; DYNJ34240I , Lot Numbers: 22JBN374; DYNJ34240I , Lot Numbers: 23JMI380; DYNJ34240I , Lot Numbers: 23KME465; DYNJ34240I , Lot Numbers: 23LMB750; DYNJ52214, Lot Numbers: 22GBM584; DYNJ52214, Lot Numbers: 23EBV426; DYNJ52214, Lot Numbers: 23FBQ525; DYNJ52214, Lot Numbers: 23LBO633; DYNJ52214, Lot Numbers: 24BBJ934; DYNJ52214, Lot Numbers: 24BBT876; DYNJ52214, Lot Numbers: 20LBO359; DYNJ53853C , Lot Numbers: 21FMA744; DYNJ53853C , Lot Numbers: 21FMB832; DYNJ53853C , Lot Numbers: 22BMG093; DYNJ53853C , Lot Numbers: 22IMG468; DYNJ57439A , Lot Numbers: 21KBR361; DYNJ57439A , Lot Numbers: 22JBF797; DYNJ57439A , Lot Numbers: 22KBK481; DYNJ57970A , Lot Numbers: 21FBT988; DYNJ58135C , Lot Numbers: 23EBB779; DYNJ58135C , Lot Numbers: 23FBD603; DYNJ58135C , Lot Numbers: 23FBT783; DYNJ58135C , Lot Numbers: 23JBT096; DYNJ58135C , Lot Numbers: 21BMA342; DYNJ58135C , Lot Numbers: 21CMC960; DYNJ58135C , Lot Numbers: 21EMA605; DYNJ58135C , Lot Numbers: 21FMA438; DYNJ58135C , Lot Numbers: 21GMD933; DYNJ58135C , Lot Numbers: 22AMF725; DYNJ58874, Lot Numbers: 22EBP939; DYNJ58874, Lot Numbers: 23FBR955; DYNJ58874, Lot Numbers: 23FBT080; DYNJ58875, Lot Numbers: 23FBM015; DYNJ58875, Lot Numbers: 23GBD061; DYNJ58875, Lot Numbers: 23JBW886; DYNJ64530, Lot Numbers: 23IBS196; DYNJ80103A , Lot Numbers: 23HBN888; DYNJ80103A , Lot Numbers: 23IBE224; DYNJ80490, Lot Numbers: 22FDB938; DYNJ82179, Lot Numbers: 23IDB760; DYNJ82179H , Lot Numbers: 23IDB760; DYNJ901348D , Lot Numbers: 22CBN435; DYNJ901348D , Lot Numbers: 22GBN021; DYNJ901348D , Lot Numbers: 22IBL110; DYNJ901348D , Lot Numbers: 22JBO112; DYNJ901348D , Lot Numbers: 23CBJ265; DYNJ901348D , Lot Numbers: 23DBG454; DYNJ901348D , Lot Numbers: 23HBJ345; DYNJ901348D , Lot Numbers: 23IBV193; DYNJ901348D , Lot Numbers: 23JBU781; DYNJ905651B , Lot Numbers: 23IMH419; DYNJ905651B , Lot Numbers: 23LMG546; DYNJ905651B , Lot Numbers: 24BME750; DYNJRA0345F , Lot Numbers: 23ABR895; DYNJRA1250B , Lot Numbers: 22EBF982; DYNJRA1250B , Lot Numbers: 23FMC743; DYNJRA1250B , Lot Numbers: 23FMF948; DYNJRA1250B , Lot Numbers: 23JMG164; DYNJRA1777 , Lot Numbers: 23CBE622; DYNJRA2352 , Lot Numbers: 24BBJ316; DYNJV0275O , Lot Numbers: 24AMH648; DYNJV0275O , Lot Numbers: 24CME159; EDUC05026, Lot Numbers: 21HDB123; EDUC05026, Lot Numbers: 21HDC026; EDUC05026, Lot Numbers: 21IDB633; EDUC05026, Lot Numbers: 21JDB157; EDUC05026, Lot Numbers: 21KDB162; EDUC05026, Lot Numbers: 21LDA686; EDUC05026, Lot Numbers: 22ADA717; EDUC05026, Lot Numbers: 22BDB179; EDUC05026, Lot Numbers: 22DDA921; EDUC1031 , Lot Numbers: 23BLA800; EDUC1031H, Lot Numbers: 23BLA800; EDUC1034 , Lot Numbers: 23CLA376; EDUC1034H, Lot Numbers: 23CLA376; MNS12465, Lot Numbers: 2022081990; MNS12670A, Lot Numbers: 2022050290; MNS9865, Lot Numbers: 2022051050; MNS9865 , Lot Numbers: 23EMI898; PAIN1396 , Lot Numbers: 22FBN139; PHS967363W , Lot Numbers: 23JMB678; SPEC0300B, Lot Numbers: 2021090750; SPEC0300B, Lot Numbers: 2022051050; SPEC0300B, Lot Numbers: 23JBD693; SPEC0300B, Lot Numbers: 23KBH304; SPEC0300B, Lot Numbers: 24ABS449; UVT1190B , Lot Numbers: 24ABS540; UVT1195 , Lot Numbers: 22FBN138; UVT1200 , Lot Numbers: 22FBN139; UVT1200H , Lot Numbers: 22FBN139; UVT1210 , Lot Numbers: 22GBH327; UVT1210 , Lot Numbers: 22JBT476; UVT1210 , Lot Numbers: 22JBU369; UVT1210 , Lot Numbers: 23FBB299; UVT1210 , Lot Numbers: 23GBA743; UVT1210 , Lot Numbers: 23JBK029; UVT1210 , Lot Numbers: 23LBM731; UVT150, Lot Numbers: 22FBX796; UVT150, Lot Numbers: 22HBN579; UVT150, Lot Numbers: 22JBI343; UVT150, Lot Numbers: 22JBN119; UVT150, Lot Numbers: 23BBJ954; UVT150, Lot Numbers: 23EBS525; UVT150, Lot Numbers: 23GBD813; UVT150, Lot Numbers: 23GBR233; UVT150, Lot Numbers: 23IBS687; UVT150, Lot Numbers: 23JBY235; UVT665A , Lot Numbers: 22FBK838; UVT665A , Lot Numbers: 22IBV837; UVT665A , Lot Numbers: 22KBQ011; UVT665A , Lot Numbers: 23GBD803; UVT665A , Lot Numbers: 23IBI160; UVT915, Lot Numbers: 23CBN895; UVT915, Lot Numbers: 23JBY224 ;

Distribution pattern

Worldwide

device · product 14 of 27

Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475

Z-2752-2024
Recall number
Z-2752-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

MNS11965A, Lot Number 2023120190; MNS12670A, Lot Number 2022030490; CIT6860A, Lot Number 2022111480; CIT6715, Lot Number 2022080190; DYNDA2271, Lot Number 2022082290; CIT7020, Lot Number 2023051290; CIT7210, Lot Number 2023073190; CIT6720A, Lot Number 2023092690; CIT6665, Lot Number 2024021990; MNS11965A, Lot Number 21CBA170 ; CIT6050 , Lot Number 22FMC986 ; CIT6050 , Lot Number 22JMG259 ; CIT6050 , Lot Number 23BMH919 ; CIT6050 , Lot Number 23CME567 ; CIT6050 , Lot Number 23HMG612 ; CIT6050 , Lot Number 23HMH514 ; CIT6050 , Lot Number 23JMI036 ; CIT6925, Lot Number 2023112190; CIT6255 , Lot Number 23BBP310 ; CIT6255 , Lot Number 23DBD372 ; CIT6255 , Lot Number 23KBD873 ; CIT6255 , Lot Number 24ABC630 ; CIT6255 , Lot Number 24ABS975 ; SPEC0300B, Lot Number 2022021001; SPEC0300B, Lot Number 2022060250; CIT6780, Lot Number 2022021001; CIT6780, Lot Number 2022060350; CIT6780, Lot Number 2023080990; CIT6920, Lot Number 2023012590; CIT6920, Lot Number 2023042490; CIT6920, Lot Number 2023080190; UVT925, Lot Number 21CBZ075 ; UVT925, Lot Number 23FMB519 ; UVT925, Lot Number 23LMB020 ; CIT4845, Lot Number 2021081850; CIT4845, Lot Number 2022122290; CIT7095, Lot Number 2023031590; MNS9865, Lot Number 2022060650; MNS8250, Lot Number 2023112290; DYNDA2497, Lot Number 2021080950; DYNDA2497, Lot Number 2021092050; DYNDA2497, Lot Number 2022030750; DYNDA2497, Lot Number 2022041150; DYNDA2497, Lot Number 2022052350; DYNDA2497, Lot Number 2022120790; DYNDA2497, Lot Number 2022120890; DYNDA2497, Lot Number 2023011290; DYNDA2497, Lot Number 2023080990; DYNDA2497, Lot Number 2023092690; DYNDA2497, Lot Number 2023120790; DYNDA2497, Lot Number 2024021990; DYNDA2496, Lot Number 2021091350; DYNDA2496, Lot Number 2023012590; DYNDH1512A, Lot Number 2022083190; DYNDH1512A, Lot Number 2022112290; DYNDH1512A, Lot Number 2022122290; DYNDH1512A, Lot Number 2023033190; UVT3594 , Lot Number 22CBX289 ; UVT3594 , Lot Number 22FBL917 ; UVT3594 , Lot Number 22JBR542 ; UVT3594 , Lot Number 23FBD767 ; UVT3594 , Lot Number 23KBA665 ; UVT3594 , Lot Number 23KBW299 ; UVT3594 , Lot Number 24ABW166 ; UVT170, Lot Number 22FBF267 ; UVT170, Lot Number 22GBH328 ; UVT170, Lot Number 22JBT833 ; UVT170, Lot Number 23ABS911 ; UVT170, Lot Number 23FBK368 ; UVT170, Lot Number 23GBR967 ; UVT170, Lot Number 23LBA508 ; UVT170, Lot Number 23LBV542 ; UVT170, Lot Number 24BBA988 ; UVT170, Lot Number 24BBO747 ; UVT170, Lot Number 21OBA615 ; UVT475, Lot Number 23CMB726 ; UVT475, Lot Number 23KMC231 ; UVT475, Lot Number 23KMJ689 ; UVT475, Lot Number 24AMB343

Distribution pattern

Worldwide

device · product 15 of 27

Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A

Z-2753-2024
Recall number
Z-2753-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDL1588A , Lot Number 23ELA011 ; DYNDL1588A , Lot Number 23HLA426 ; DYNDL1588A , Lot Number 23JLA181 ; DYNDL1588A , Lot Number 24ALA515

Distribution pattern

Worldwide

device · product 16 of 27

Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A

Z-2754-2024
Recall number
Z-2754-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

MNS12670A, Lot Number 2022112990

Distribution pattern

Worldwide

device · product 17 of 27

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

Z-2755-2024
Recall number
Z-2755-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CIT6715, Lot Number 2023011090; CIT6920, Lot Number 2021081890; DT18415 , Lot Number 22OBA722 ; DT18415 , Lot Number 22JBQ737 ; DT18415 , Lot Number 23BBE570 ; DT18415 , Lot Number 23DBS680 ; DT18415 , Lot Number 23EBS516 ; DT18415 , Lot Number 23HBN856 ; DT18415 , Lot Number 23JBV086 ; DT18415 , Lot Number 21BBF570 ; DT18415 , Lot Number 21CBO659 ; DT18415 , Lot Number 24CBM583 ; DYNDH1512, Lot Number 2021120690

Distribution pattern

Worldwide

device · product 18 of 27

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

Z-2756-2024
Recall number
Z-2756-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CIT6715, Lot Number 2023071390; CIT6920, Lot Number 2021071290; CIT7095, Lot Number 2021071290; CIT7095, Lot Number 2022110390; MNS12465, Lot Number 2023081590; DYNDH1512, Lot Number 2021070790; DYNDH1512, Lot Number 2021080290; DYNDH1512, Lot Number 2022011990; DYNDH1512A, Lot Number 2022110390; DYNDH1512A, Lot Number 2023052290; DYNDH1512A, Lot Number 2023071390; DYNDH1512A, Lot Number 2024022690

Distribution pattern

Worldwide

device · product 19 of 27

Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE BED KIT, Pack Number DYKL1839; 7) GIRAFFE BED KIT, Pack Number DYKL1839H; 8) NEWBORN SUPPLIES, Pack Number ACC010791; 9) NEWBORN SUPPLIES + POSTPARTUM, Pack Number ACC010597C; 10) NEWBORN KIT, Pack Number DYKL1803

Z-2757-2024
Recall number
Z-2757-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKB1011C, Lot Number 23ABQ306 ; DYKB1011C, Lot Number 23BBT085 ; DYKB1011C, Lot Number 23CBX152 ; DYKB1011C, Lot Number 23EBE383 ; DYKB1011C, Lot Number 23HBM160 ; DYKB1011C, Lot Number 23JBQ260 ; DYKB1011C, Lot Number 24BBM242 ; DYKB1011B, Lot Number 22DBB502 ; DYKB1011B, Lot Number 22FBS047 ; DYKB1011B, Lot Number 22HBO787 ; DYKB1011B, Lot Number 22KBB475 ; DYKP1021 , Lot Number 23FBK519 ; DYKP1021 , Lot Number 24ABO781 ; DYKP1021 , Lot Number 24ABW188 ; DYKP1021 , Lot Number 24ABX254 ; DYKM2149 , Lot Number 23ABU332 ; DYKM2149 , Lot Number 23BBL263 ; DYKM2149 , Lot Number 23HBF070 ; DYKM2149 , Lot Number 23JBE447 ; DYKM2149A, Lot Number 23LBJ716 ; DYKM2149A, Lot Number 24ABO812 ; DYKL1839 , Lot Number 22LBT106 ; DYKL1839 , Lot Number 23DBL613 ; DYKL1839 , Lot Number 23GBJ764 ; DYKL1839 , Lot Number 23JBK240 ; DYKL1839H, Lot Number 22LBT106 ; DYKL1839H, Lot Number 23DBL613 ; DYKL1839H, Lot Number 23GBJ764 ; DYKL1839H, Lot Number 23JBK240 ; ACC010791, Lot Number 24BDB871 ; ACC010597C , Lot Number 23HDB884 ; ACC010597C , Lot Number 23IDA286 ; ACC010597C , Lot Number 23JDA167 ; ACC010597C , Lot Number 23JDA499 ; ACC010597C , Lot Number 23JDA801 ; ACC010597C , Lot Number 23JDB763 ; ACC010597C , Lot Number 23JDB813 ; ACC010597C , Lot Number 23KDB477 ; DYKL1803 , Lot Number 21KBI050 ; DYKL1803 , Lot Number 22GBJ686 ; DYKL1803 , Lot Number 22HBN282 ; DYKL1803 , Lot Number 22IBP034 ; DYKL1803 , Lot Number 22JBH897 ; DYKL1803 , Lot Number 23BBN707 ; DYKL1803 , Lot Number 23CBR949 ; DYKL1803 , Lot Number 23FBJ793 ; DYKL1803 , Lot Number 23HBI726 ; DYKL1803 , Lot Number 23HBY914

Distribution pattern

Worldwide

device · product 20 of 27

Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497

Z-2758-2024
Recall number
Z-2758-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

SPEC0300B, Lot Number 2022033050; CIT6780, Lot Number 2022042550; CIT4845, Lot Number 2022032450; MNS9865, Lot Number 2022021850; MNS9865, Lot Number 2022041850; DYNDA2497, Lot Number 2022042650

Distribution pattern

Worldwide

device · product 21 of 27

Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B

Z-2759-2024
Recall number
Z-2759-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ55909B, Lot Number 23IBB122

Distribution pattern

Worldwide

device · product 22 of 27

Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097

Z-2760-2024
Recall number
Z-2760-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKM1426 , Lot Numbers: 21HME852; DYKM1426 , Lot Numbers: 21JMB937; DYKM1426 , Lot Numbers: 22AMC931; DYKM1426 , Lot Numbers: 22BMH636; DYKM1426 , Lot Numbers: 22GMC855; DYKM1426 , Lot Numbers: 22HMD453; DYKM1426 , Lot Numbers: 22JMA597; DYKM1426 , Lot Numbers: 22LMF030; DYKM1426 , Lot Numbers: 23JMB439; DYKM1426 , Lot Numbers: 24AMF833; DYNJ908583, Lot Numbers: 23BBI474; DYNJ908583, Lot Numbers: 23GBU194; DYNJ908583, Lot Numbers: 23HBI662; DYNJ908583A , Lot Numbers: 23HBU557; DYNJ908583A , Lot Numbers: 23JBD374; DYNJ908583A , Lot Numbers: 23KBO704; DYNJ908583A , Lot Numbers: 23KBW138; DYNJ908583A , Lot Numbers: 24ABB089; DYNJ908583A , Lot Numbers: 24BBD662; DYNJ908583A , Lot Numbers: 24BBS919; DYNJ908583A , Lot Numbers: 24CBB994; DYNJ909097, Lot Numbers: 23EBQ501; DYNJ909097, Lot Numbers: 23FBH520; DYNJ909097, Lot Numbers: 23GBD905; DYNJ909097, Lot Numbers: 23HBP109; DYNJ909097, Lot Numbers: 23HBY982; DYNJ909097, Lot Numbers: 23IBM281

Distribution pattern

Worldwide

device · product 23 of 27

Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION TRAY , Pack Number DYNDL1889; 8) CIRCUMCISION TRAY , Pack Number CIT7455H ; 9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075; 10) CIRCUMCISON TRAY, Pack Number CIT7380; 11) HOSPITAL CIRCUMCISION T, Pack Number CIT2825; 12) CIRCUMCISION TRAY , Pack Number CIT6135A ; 13) CIRCUMCISION TRAY , Pack Number CIT6135B ; 14) NICU CIRCUMCISION SET, Pack Number CIT6900;

Z-2761-2024
Recall number
Z-2761-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CIT6335, Lot Number 22IBT528 ; CIT6135BH, Lot Number 22OBI417 ; CIT6135BH, Lot Number 22FBX794 ; CIT6135BH, Lot Number 23CBQ475 ; CIT6135BH, Lot Number 23CBT677 ; CIT6135BH, Lot Number 23EBP345 ; CIT6135BH, Lot Number 23LBI785 ; CIT6135BH, Lot Number 24BBT038 ; CIT2465, Lot Number 21BBH212 ; CIT4920, Lot Number 22GBS036 ; CIT4920, Lot Number 22IBF469 ; CIT4920, Lot Number 23CBG366 ; CIT4920, Lot Number 23IBL492 ; CIT7455, Lot Number 23GBV732 ; DYNDA3045, Lot Number 23FBO420 ; DYNDA3045, Lot Number 23GBI869 ; DYNDA3045, Lot Number 23IBR354 ; DYNDL1889, Lot Number 23GLB117 ; DYNDL1889, Lot Number 23ILA455 ; CIT7455H , Lot Number 23GBV732 ; CIT6075, Lot Number 22DBD285 ; CIT6075, Lot Number 22EBV624 ; CIT6075, Lot Number 23ABM531 ; CIT6075, Lot Number 23CBC554 ; CIT6075, Lot Number 23CBH405 ; CIT6075, Lot Number 23EBC481 ; CIT6075, Lot Number 23EBS480 ; CIT6075, Lot Number 23FBT595 ; CIT6075, Lot Number 23IBT726 ; CIT7380, Lot Number 22GBM440 ; CIT7380, Lot Number 24BBM689 ; CIT2825, Lot Number 22JBI550 ; CIT2825, Lot Number 23BBR929 ; CIT2825, Lot Number 23GBD786 ; CIT2825, Lot Number 23IBL941 ; CIT6135A , Lot Number 21CBG443 ; CIT6135A , Lot Number 21CBG766 ; CIT6135B , Lot Number 22OBI417 ; CIT6135B , Lot Number 22FBX794 ; CIT6135B , Lot Number 23CBQ475 ; CIT6135B , Lot Number 23CBT677 ; CIT6135B , Lot Number 23EBP345 ; CIT6135B , Lot Number 23LBI785 ; CIT6135B , Lot Number 24BBT038 ; CIT6900, Lot Number 21LBB097 ; CIT6900, Lot Number 22GBF169 ; CIT6900, Lot Number 22IBR336 ; CIT6900, Lot Number 23DBE643

Distribution pattern

Worldwide

device · product 24 of 27

Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

Z-2762-2024
Recall number
Z-2762-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ908584 , Lot Numbers: 22DBL462; DYNJ908584 , Lot Numbers: 22JBS694; DYNJ908584 , Lot Numbers: 23CBQ227; DYNJ908584 , Lot Numbers: 23FBT227; DYNJ908584A, Lot Numbers: 23HBQ685; DYNJ908584A, Lot Numbers: 23JBT134; DYNJ908584A, Lot Numbers: 23LBE682; DYNJ908584A, Lot Numbers: 24CBH741; DYNJ909098 , Lot Numbers: 22LBS559; DYNJ909098 , Lot Numbers: 23EBQ496; DYNJ909098 , Lot Numbers: 23FBG194; DYNJ909098 , Lot Numbers: 23GBK039; DYNJ909098 , Lot Numbers: 23GBQ855; DYNJ909098 , Lot Numbers: 23IBK300; DYNJ909098 , Lot Numbers: 23IBQ772

Distribution pattern

Worldwide

device · product 25 of 27

Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B

Z-2763-2024
Recall number
Z-2763-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ40348G, Lot Number 23HBR333; DYNJ63036B, Lot Number 23IDC131

Distribution pattern

Worldwide

device · product 26 of 27

Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT, Pack Number DYNJ67344; 8) BYERS CATARACT, Pack Number DYNJ67344H ; 9) CATARACT, Pack Number DYNJ44544B ; 10) CATARACT, Pack Number DYNJ54713C ; 11) CATARACT CDS , Pack Number CDS983804F ; 12) CATARACT CDS, Pack Number CDS983804F ; 13) CATARACT DR MALONE PACK , Pack Number DYNJ51590A ; 14) CATARACT DR MULROONEY PACK, Pack Number DYNJ51595A ; 15) CATARACT DR STEVENS PACK, Pack Number DYNJ51593C ; 16) CATARACT L J, Pack Number DYNJ40056A ; 17) CATARACT PACK, Pack Number CMPJ03235C ; 18) CATARACT PACK, Pack Number DYNJ80316A ; 19) CATARACT PACK, Pack Number VAL011CTASF; 20) CATARACT PACK , Pack Number CMPJ03235C ; 21) CATARACT PACK , Pack Number DYNJ31020K ; 22) CATARACT PACK , Pack Number DYNJ31020L ; 23) CATARACT PACK , Pack Number DYNJ54790D ; 24) CATARACT PACK , Pack Number DYNJ64962; 25) CATARACT PACK , Pack Number DYNJ80316; 26) CATARACT PACK , Pack Number DYNJ80316A ; 27) CATARACT PACK , Pack Number DYNJ80487A ; 28) CATARACT PACK , Pack Number DYNJ80487B ; 29) CATARACT PACK , Pack Number DYNJ80487C ; 30) CATARACT PACK , Pack Number DYNJ80487F ; 31) CATARACT PACK , Pack Number DYNJ84265A ; 32) CATARACT PACK , Pack Number DYNJ85332; 33) CATARACT PACK , Pack Number LYN042CPFEG; 34) CATARACT PACK , Pack Number VAL011CTASF; 35) CATARACT PACK , Pack Number DYNJ43048K ; 36) CATARACT PACK , Pack Number DYNJ52649D ; 37) CATARACT PACK , Pack Number DYNJ52649F ; 38) CATARACT PACK , Pack Number DYNJ55682D ; 39) CATARACT PACK , Pack Number DYNJ63284A ; 40) CATARACT PACK , Pack Number DYNJ63284B ; 41) CATARACT PACK , Pack Number DYNJ66410B ; 42) CATARACT PACK , Pack Number DYNJ85042; 43) CATARACT PACK , Pack Number DYNJ68836B ; 44) CATARACT PACK - GB, Pack Number DYNJ54790F ; 45) CATARACT PACK LUTHER HOSPITAL , Pack Number DYNJ61699D ; 46) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232; 47) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232H ; 48) CATARACT PACK-LF, Pack Number DYNJ42830D ; 49) CATARACT PACK-LF, Pack Number DYNJ0200004B ; 50) CATARACT PACK-LF, Pack Number DYNJ36100C ; 51) CATARACT TRAY , Pack Number DYNJ44356I ; 52) CATARACT TRAY , Pack Number DYNJ44356J ; 53) CATARACT TRAY , Pack Number DYNJ62410A ; 54) COVENANT RETINAL TRAY , Pack Number EYT102K; 55) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 56) CUSTOM EYE TRAY #1, Pack Number DYNJ66003C ; 57) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 58) CUSTOM EYE TRAY #2 , Pack Number DYNJ66004B ; 59) CUSTOM EYE TRAY #2, Pack Number DYNJ66004A ; 60) CUSTOM EYE TRAY #2, Pack Number DYNJ66004B ; 61) DDD VITRECTOMY PACK-LF, Pack Number DYNJ19973S ; 62) DR FLOOD EYE PACK , Pack Number DYNJ57258G ; 63) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671C ; 64) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671D ; 65) EYE , Pack Number DYNJ0559863K ; 66) EYE BCS PACK, Pack Number DYNJ37682J ; 67) EYE BCS PACK, Pack Number DYNJ37682K ; 68) EYE CATARACT (BASIC EYE), Pack Number DYNJ63272B ; 69) EYE INJECTION KIT , Pack Number MNS13080 ; 70) EYE MUSCLE PACK , Pack Number DYNJ66022A ; 71) EYE MUSCLE TRAY FFX , Pack Number DYNJ63638A ; 72) EYE PACK, Pack Number DYNJ40135C ; 73) EYE PACK, Pack Number DYNJ55484A ; 74) EYE PACK, Pack Number DYNJ60960A ; 75) EYE PACK, Pack Number DYNJ67973B ; 76) EYE PACK, Pack Number DYNJ83799C ; 77) EYE PACK, Pack Number VAL013EPWEC; 78) EYE PACK, Pack Number VAL038BSCLC; 79) EYE PACK, Pack Number DYNJ56293D ; 80) EYE PACK, Pack Number DYNJ64051C ; 81) EYE PACK, Pack Number CMPJ06528F ; 82) EYE PACK, Pack Number DYNJ38400I ; 83) EYE PACK, Pack Number DYNJ38400J ; 84) EYE PACK, Pack Number DYNJ64284C ; 85) EYE PACK, Pack Number DYNJ64284D ; 86) EYE PACK, Pack Numbe

Z-2764-2024
Recall number
Z-2764-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ51654A , Lot Number:23HBZ446 ; DYNJ0855117O , Lot Number:23GME420 ; DYNJ0855117O , Lot Number:23IMA529 ; DYNJ0855117O , Lot Number:24AMG373 ; DYNJ53847D , Lot Number:23AMJ016 ; DYNJ53847D , Lot Number:23EMJ451 ; DYNJ53847D , Lot Number:23FMF604 ; DYNJ53847D , Lot Number:23JMI394 ; DYNJ53847D , Lot Number:23KMB963 ; DYNJ53847D , Lot Number:24AMA722 ; DYNJ83699A , Lot Number:24CMG922 ; DYNJ81805, Lot Number:23FMD167 ; DYNJ81805, Lot Number:23GMA680 ; DYNJ81805, Lot Number:23JMD040 ; DYNJ81805, Lot Number:24AMA541 ; DYNJ83699A , Lot Number:23KMA807 ; DYNJ83699A , Lot Number:24AMB925 ; DYNJ67344, Lot Number:23IMH376 ; DYNJ67344, Lot Number:23JMG829 ; DYNJ67344H , Lot Number:23IMH376 ; DYNJ67344H , Lot Number:23JMG829 ; DYNJ44544B , Lot Number:24BBN345 ; DYNJ54713C , Lot Number:23GBR621 ; CDS983804F , Lot Number:24CBG535 ; CDS983804F , Lot Number:23BBN605 ; CDS983804F , Lot Number:23BBU281 ; CDS983804F , Lot Number:23EBC831 ; CDS983804F , Lot Number:23EBW202 ; CDS983804F , Lot Number:23FBH069 ; CDS983804F , Lot Number:23HBD970 ; CDS983804F , Lot Number:23IBC407 ; CDS983804F , Lot Number:23JBF548 ; DYNJ51590A , Lot Number:21KBS483 ; DYNJ51590A , Lot Number:21KBS490 ; DYNJ51590A , Lot Number:22GBD368 ; DYNJ51590A , Lot Number:22JBL806 ; DYNJ51590A , Lot Number:22JBU147 ; DYNJ51590A , Lot Number:22JBW972 ; DYNJ51590A , Lot Number:23FBR199 ; DYNJ51590A , Lot Number:23IBJ742 ; DYNJ51590A , Lot Number:23JBK026 ; DYNJ51595A , Lot Number:21IBN715 ; DYNJ51595A , Lot Number:21KBJ227 ; DYNJ51595A , Lot Number:21LBQ210 ; DYNJ51595A , Lot Number:22FBB062 ; DYNJ51595A , Lot Number:22GBN540 ; DYNJ51595A , Lot Number:22IBU646 ; DYNJ51595A , Lot Number:23ABO675 ; DYNJ51595A , Lot Number:23CBL791 ; DYNJ51595A , Lot Number:23EBA140 ; DYNJ51595A , Lot Number:23IBM004 ; DYNJ51593C , Lot Number:21KBI577 ; DYNJ51593C , Lot Number:21KBT571 ; DYNJ51593C , Lot Number:21LBT302 ; DYNJ51593C , Lot Number:22JBA148 ; DYNJ51593C , Lot Number:23BBK907 ; DYNJ40056A , Lot Number:23HMG522 ; DYNJ40056A , Lot Number:23KMB058 ; CMPJ03235C , Lot Number:24CBJ839 ; DYNJ80316A , Lot Number:24CBF142 ; VAL011CTASF, Lot Number:24CBL957 ; CMPJ03235C , Lot Number:23BBB565 ; CMPJ03235C , Lot Number:23GBO681 ; CMPJ03235C , Lot Number:24BBI378 ; DYNJ31020K , Lot Number:21LBL497 ; DYNJ31020K , Lot Number:22OBC488 ; DYNJ31020K , Lot Number:22FBT609 ; DYNJ31020K , Lot Number:22HBA842 ; DYNJ31020K , Lot Number:23BBB378 ; DYNJ31020K , Lot Number:23CBJ094 ; DYNJ31020K , Lot Number:23DBQ602 ; DYNJ31020K , Lot Number:23FBK551 ; DYNJ31020K , Lot Number:23JBT069 ; DYNJ31020K , Lot Number:20XBG244 ; DYNJ31020K , Lot Number:21EBB373 ; DYNJ31020L , Lot Number:23LBO289 ; DYNJ31020L , Lot Number:23LBS944 ; DYNJ54790D , Lot Number:21KBK564 ; DYNJ54790D , Lot Number:21LBP312 ; DYNJ64962, Lot Number:22EBE357 ; DYNJ64962, Lot Number:22GBM208 ; DYNJ64962, Lot Number:23CBM665 ; DYNJ64962, Lot Number:23DBC274 ; DYNJ64962, Lot Number:23EBD021 ; DYNJ64962, Lot Number:23FBV254 ; DYNJ64962, Lot Number:21ABD721 ; DYNJ64962, Lot Number:21ABG947 ; DYNJ80316, Lot Number:22GBK573 ; DYNJ80316A , Lot Number:23EBX492 ; DYNJ80316A , Lot Number:23KBB868 ; DYNJ80316A , Lot Number:23LBE622 ; DYNJ80316A , Lot Number:24ABA118 ; DYNJ80316A , Lot Number:24ABQ972 ; DYNJ80316A , Lot Number:24BBL220 ; DYNJ80487A , Lot Number:22HBI178 ; DYNJ80487B , Lot Number:23BBR916 ; DYNJ80487B , Lot Number:23CBP361 ; DYNJ80487C , Lot Number:23FBO339 ; DYNJ80487C , Lot Number:23GBO642 ; DYNJ80487C , Lot Number:23GBR276 ; DYNJ80487C , Lot Number:23HBP753 ; DYNJ80487F , Lot Number:23KBF204 ; DYNJ80487F , Lot Number:23KBF967 ; DYNJ80487F , Lot Number:24BBJ804 ; DYNJ84265A , Lot Number:23LBP047 ; DYNJ84265A , Lot Number:24ABU345 ; DYNJ85332, Lot Number:23KBM469 ; LYN042CPFEG, Lot Number:21LBM245 ; VAL011CTASF, Lot Number:23CBI687 ; VAL011CTASF, Lot Number:23DBO423 ; VAL011CTASF, Lot Number:23FBD539 ; VAL011CTASF, Lot Number:23IBE673 ; VAL011CTASF, Lot Number:23KBC654 ; VAL011CTASF, Lot Number:23LBG127 ; DYNJ43048K , Lot Number:23JMF537 ; DYNJ52649D , Lot Number:21CMD757 ; DYNJ52649D , Lot Number:21HMD666 ; DYNJ52649F , Lot Number:23FMJ496 ; DYNJ52649F , Lot Number:23GMC382 ; DYNJ52649F , Lot Number:23HME435 ; DYNJ52649F , Lot Number:23KMF720 ; DYNJ52649F , Lot Number:23LMG694 ; DYNJ54790D , Lot Number:23AMB680 ; DYNJ55682D , Lot Number:23JMB655 ; DYNJ63284A , Lot Number:21HMA782 ; DYNJ63284A , Lot Number:22DME834 ; DYNJ63284A , Lot Number:23CMA698 ; DYNJ63284B , Lot Number:23GMH292 ; DYNJ63284B , Lot Number:23KMB077 ; DYNJ63284B , Lot Number:24AMB323 ; DYNJ64962, Lot Number:23KMH920 ; DYNJ66410B , Lot Number:23JMB324 ; DYNJ85042, Lot Number:23JMD316 ; DYNJ68836B , Lot Number:23KLA266 ; DYNJ68836B , Lot Number:23LLB070 ; DYNJ54790F , Lot Number:23JMC258 ; DYNJ54790F , Lot Number:23LMI220 ; DYNJ61699D , Lot Number:23HBI192 ; DYNJ80232, Lot Number:24ABL377 ; DYNJ80232H , Lot Number:24ABL377 ; DYNJ42830D , Lot Number:23IBA622 ; DYNJ0200004B , Lot Number:23GMI902 ; DYNJ36100C , Lot Number:22KMH152 ; DYNJ44356I , Lot Number:22FBL880 ; DYNJ44356I , Lot Number:22HBA943 ; DYNJ44356I , Lot Number:23BBL664 ; DYNJ44356I , Lot Number:23DBC100 ; DYNJ44356I , Lot Number:23FBK101 ; DYNJ44356J , Lot Number:23HBJ438 ; DYNJ44356J , Lot Number:23JBB906 ; DYNJ44356J , Lot Number:23LBA253 ; DYNJ44356J , Lot Number:24ABQ985 ; DYNJ44356J , Lot Number:24BBC038 ; DYNJ44356J , Lot Number:24BBL641 ; DYNJ62410A , Lot Number:23GBS482 ; DYNJ62410A , Lot Number:23HBN329 ; EYT102K, Lot Number:23IDA309 ; DYNJ66003D , Lot Number:24CBE592 ; DYNJ66003C , Lot Number:21FBK406 ; DYNJ66003C , Lot Number:21CBM686 ; DYNJ66003C , Lot Number:21DBT747 ; DYNJ66003D , Lot Number:22FBC039 ; DYNJ66003D , Lot Number:23JBE968 ; DYNJ66003D , Lot Number:23JBQ750 ; DYNJ66003D , Lot Number:24ABO688 ; DYNJ66003D , Lot Number:24BBG701 ; DYNJ66004B , Lot Number:24CBE607 ; DYNJ66004A , Lot Number:20LBE742 ; DYNJ66004B , Lot Number:21FBT041 ; DYNJ66004B , Lot Number:22EBR001 ; DYNJ66004B , Lot Number:22FBS391 ; DYNJ66004B , Lot Number:24BBL458 ; DYNJ19973S , Lot Number:23JME916 ; DYNJ57258G , Lot Number:23IBB036 ; DYNJ44671C , Lot Number:21HDB625 ; DYNJ44671D , Lot Number:22ADA848 ; DYNJ44671D , Lot Number:22CDA486 ; DYNJ0559863K , Lot Number:23LMA799 ; DYNJ37682J , Lot Number:23BMD927 ; DYNJ37682K , Lot Number:23HMD991 ; DYNJ63272B , Lot Number:23IBG537 ; MNS13080 , Lot Number:21DBC890 ; DYNJ66022A , Lot Number:23HBR314 ; DYNJ66022A , Lot Number:23HBR356 ; DYNJ63638A , Lot Number:23IBE732 ; DYNJ40135C , Lot Number:23GBW482 ; DYNJ55484A , Lot Number:21KBH827 ; DYNJ55484A , Lot Number:21LBO808 ; DYNJ55484A , Lot Number:22FBJ347 ; DYNJ55484A , Lot Number:23HBM901 ; DYNJ55484A , Lot Number:23IBR023 ; DYNJ60960A , Lot Number:23BBJ999 ; DYNJ60960A , Lot Number:23CBS340 ; DYNJ60960A , Lot Number:23EBD517 ; DYNJ60960A , Lot Number:23FBI464 ; DYNJ60960A , Lot Number:23GBM127 ; DYNJ67973B , Lot Number:24ABM354 ; DYNJ83799C , Lot Number:23HBM374 ; DYNJ83799C , Lot Number:23IBE242 ; VAL013EPWEC, Lot Number:23IBD749 ; VAL038BSCLC, Lot Number:21FBI402 ; VAL038BSCLC, Lot Number:22FBI684 ; VAL038BSCLC, Lot Number:22GBI953 ; VAL038BSCLC, Lot Number:22HBE695 ; VAL038BSCLC, Lot Number:22HBH463 ; VAL038BSCLC, Lot Number:23BBP414 ; VAL038BSCLC, Lot Number:23CBA206 ; VAL038BSCLC, Lot Number:23GBN565 ; VAL038BSCLC, Lot Number:23IBQ356 ; VAL038BSCLC, Lot Number:23JBQ925 ; VAL038BSCLC, Lot Number:20IBH345 ; VAL038BSCLC, Lot Number:24ABL864 ; VAL038BSCLC, Lot Number:24BBP892 ; VAL038BSCLC, Lot Number:20LBY788 ; VAL038BSCLC, Lot Number:21CBV826 ; VAL038BSCLC, Lot Number:21FBE159 ; DYNJ56293D , Lot Number:23IDB161 ; DYNJ64051C , Lot Number:23CDC473 ; DYNJ64051C , Lot Number:23GDA852 ; CMPJ06528F , Lot Number:23KMA165 ; DYNJ38400I , Lot Number:21IMA857 ; DYNJ38400I , Lot Number:21IMH583 ; DYNJ38400I , Lot Number:22DMD856 ; DYNJ38400J , Lot Number:23KMG804 ; DYNJ60960A , Lot Number:22EMA599 ; DYNJ64284C , Lot Number:21HMA162 ; DYNJ64284C , Lot Number:23CMA702 ; DYNJ64284D , Lot Number:23FMJ780 ; DYNJ64284D , Lot Number:23KMD668 ; DYNJ64284D , Lot Number:23LMD080 ; DYNJ64284D , Lot Number:24AMG449 ; DYNJ64051D , Lot Number:23LLA491 ; VAL013EPFEG, Lot Number:23IBQ281 ; VAL013EPFEI, Lot Number:23LBH694 ; DYNJ63096A , Lot Number:23FBC693 ; DYNJ63096A , Lot Number:23GBW469 ; DYNJ0516258W , Lot Number:23KMB305 ; DYNJ0559777C , Lot Number:21HMC030 ; DYNJ0559777C , Lot Number:22CMH758 ; DYNJ0559777D , Lot Number:23EMK184 ; DYNJ0559777F , Lot Number:23GMG783 ; DYNJ0559777F , Lot Number:23JME881 ; DYNJ0559777F , Lot Number:23KMB427 ; DYNJ0559777F , Lot Number:24AMB790 ; DYNJ53097C , Lot Number:23IBE728 ; DYNJ27580F , Lot Number:22OBG462 ; DYNJ27580F , Lot Number:22FBR432 ; DYNJ27580F , Lot Number:22GBX560 ; DYNJ27580F , Lot Number:22JBE628 ; DYNJ27580F , Lot Number:22JBT093 ; DYNJ27580F , Lot Number:23BBO703 ; DYNJ27580G , Lot Number:23CBP779 ; DYNJ27580G , Lot Number:23DBS205 ; DYNJ27580G , Lot Number:23FBC630 ; DYNJ27580G , Lot Number:23GBC544 ; DYNJ27580G , Lot Number:23HBM937 ; DYNJ27580G , Lot Number:23KBQ070 ; DYNJ21627L , Lot Number:24AMF970 ; DYNJ81183A , Lot Number:22GBM466 ; DYNJ53678B , Lot Number:21LBJ879 ; DYNJ53678B , Lot Number:22FBY588 ; DYNJ53678B , Lot Number:22IBQ735 ; DYNJ53678B , Lot Number:23BBQ152 ; DYNJ53678B , Lot Number:23HBP513 ; DYNJ66038A , Lot Number:23HBT377 ; DYNJ0608576P , Lot Number:23JME914 ; DYNJ67519A , Lot Number:23HBT970 ; DYNJ67519A , Lot Number:23IBE623 ; DYNJ902885D, Lot Number:23IBD838 ; DYNJ902885D, Lot Number:23IBD935 ; DYNJ902885D, Lot Number:23IBM274 ; DYNJ54393D , Lot Number:23HBK063 ; DYNJ34288K , Lot Number:22OBB445 ; DYNJ34288K , Lot Number:22GBF074 ; DYNJ34288K , Lot Number:22HBK556 ; DYNJ34288K , Lot Number:23CBC625 ; DYNJ38109C , Lot Number:21KBT541 ; DYNJ38109C , Lot Number:21LBK050 ; DYNJ38109C , Lot Number:22IBS327 ; DYNJ38109C , Lot Number:23BBA458 ; DYNJ38109C , Lot Number:23GBF633 ; DYNJ38109C , Lot Number:23GBI442 ; DYNJ38109C , Lot Number:23IBC961 ; DYNJ67973A , Lot Number:22JBK486 ; DYNJ67973A , Lot Number:23ABM186 ; DYNJ67973A , Lot Number:23GBI608 ; DYNJ67973A , Lot Number:23IBC924 ; DYNJ55840A , Lot Number:21GMD889 ; DYNJ55840A , Lot Number:21IMC582 ; DYNJ55840A , Lot Number:22AMC428 ; DYNJ55840A , Lot Number:22CMH721 ; DYNJ55840A , Lot Number:23FMJ603 ; DYNJ55840A , Lot Number:23KMC842 ; DYNJ82201, Lot Number:23IDA107 ; DYNJ901206D, Lot Number:22HBW709 ; DYNJ901206D, Lot Number:23DBP697 ; CMPJ05506D , Lot Number:22HBH563 ; CMPJ05506D , Lot Number:23CBH848 ; DYNJ65156A , Lot Number:23KDA430 ; DYNJ47273I , Lot Number:22LMD338 ; DYNJ80556C , Lot Number:24ABL912 ; DYNJ60631B , Lot Number:23HBP777 ; DYNJ60631B , Lot Number:23HBZ160 ; DYNJVB91043A , Lot Number:23JDC086 ; DYNJVB91043A , Lot Number:23KDB345 ; CMPJ11101, Lot Number:23IDB922 ; CMPJ11101, Lot Number:23JDA637 ; DYNJ42845D , Lot Number:23IBA707 ; DYNJ44507J , Lot Number:23HBV391 ; DYNJ85449, Lot Number:24ABD671 ; DYNJ57970C , Lot Number:23CBS337 ; DYNJ57970C , Lot Number:23DBB080 ; DYNJ57970D , Lot Number:23JBT640 ; DYNJ57970D , Lot Number:23KBN028 ; DYNJ57970D , Lot Number:24ABB977 ; DYNJ57970D , Lot Number:24ABV141 ; DYNJ34159D , Lot Number:23HBV666 ; DYNJ80483, Lot Number:24ABK886 ; DYNJ66624A , Lot Number:23GMG818 ; DYNJ81824, Lot Number:23HBP061 ; DYNJ68627, Lot Number:21CBM277 ; DYNJ68627B , Lot Number:23IBC749 ; DYNJ68627B , Lot Number:23GMB879 ; DYNJ68627C , Lot Number:24AMB768 ; DYNJ43818, Lot Number:22AMD337 ; DYNJ43818, Lot Number:23BMC400 ; DYNJ43818, Lot Number:23GMI178 ; DYNJ43818, Lot Number:23JMK100 ; CMPJ21591J , Lot Number:23HBI095 ; DYNJ60021A , Lot Number:23HBT040 ; DYNJ43050N , Lot Number:23JMG418 ; CDS810023J , Lot Number:23HBV221 ; DYNJ900374N, Lot Number:22FBB171 ; DYNJ900374N, Lot Number:22FBC598 ; DYNJ900374N, Lot Number:22HBV856 ; CMPJ04908M , Lot Number:22EBF948 ; CMPJ04908M , Lot Number:22HBK544 ; DYNJ83503, Lot Number:23CMC327 ; DYNJ83503, Lot Number:23GMD280 ; DYNJ83503, Lot Number:23JMF577 ; DYNJ53853F , Lot Number:23KMB732 ; DYNJ20988G , Lot Number:21JMG468 ; DYNJ20988G , Lot Number:22AME490 ; DYNJ20988G , Lot Number:22CMA075 ; DYNJ20988G , Lot Number:22DME734 ; DYNJ20988G , Lot Number:22FMA831 ; DYNJ20988G , Lot Number:22GMC750 ; DYNJ20988G , Lot Number:22HMC747 ; DYNJ20988G , Lot Number:22IME434 ; DYNJ20988G , Lot Number:22LMD535 ; DYNJ37739L , Lot Number:23IBE128 ; DYNJ40839A , Lot Number:23KMC318 ; DYNJ40839A , Lot Number:24AMF192 ; DYNJ80114, Lot Number:21KMD689 ; DYNJ80114, Lot Number:22AMF833 ; DYNJ80114, Lot Number:22DMD369 ; DYNJ80114A , Lot Number:23BMB820 ; DYNJ80114A , Lot Number:23FMF556 ; DYNJ80114A , Lot Number:23GMD277 ; DYNJ80114A , Lot Number:23HMB645 ; DYNJ80114A , Lot Number:23HMH770 ; DYNJ80114A , Lot Number:23JMD209 ; DYNJ80114A , Lot Number:23KMB513 ; DYNJ80114A , Lot Number:23LMA560 ; VAL043VPASC, Lot Number:21LBR917 ; DYNJVB1080A, Lot Number:23IDA988 ; DYNJ55508B , Lot Number:22KBF091 ; DYNJ55508B , Lot Number:23BBI775 ; DYNJ55508B , Lot Number:23CBB250 ; DYNJ55508B , Lot Number:23EBB305 ; DYNJ55508B , Lot Number:23EBV036 ; DYNJ55508B , Lot Number:24ABW624 ; DYNJ55508B , Lot Number:24BBR693 ; DYNDA2857, Lot Number:22JME670 ; DYNDA2857A , Lot Number:23GME382 ; DYNDA2857A , Lot Number:23JMG571 ; DYNJ38495J , Lot Number:23HMG757 ; DYNJ0843936F , Lot Number:22ADB686 ; DYNJ0843936F , Lot Number:22JDA822 ; DYNJ0843936G , Lot Number:22KDB025 ; DYNJ0843936G , Lot Number:23ADA378 ; DYNJ0843936I , Lot Number:23JDA380 ; DYNJ46536F , Lot Number:21DMA451 ; DYNJ46536F , Lot Number:21FMA586 ; DYNJ46536F , Lot Number:21IMB516 ; DYNJ46536G , Lot Number:22AMD760 ; DYNJ46536G , Lot Number:22CMH930 ; DYNJ46536G , Lot Number:22DMC362 ; DYNJ46536G , Lot Number:22DMF054 ; DYNJ46536G , Lot Number:23EMJ440 ; DYNJ46536I , Lot Number:23GMI800 ; DYNJ82153, Lot Number:22ILA613 ; DYNJ82153, Lot Number:23DLA980 ; DYNJ82153, Lot Number:24BLB069

Distribution pattern

Worldwide

device · product 27 of 27

Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7) ARTHROGRAM TRAY , Pack Number PAIN1396 ; 8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ; 9) ARTHROGRAPH TRAY, Pack Number MNS12670B; 10) ARTHROSCOPY , Pack Number DYNJ909699 ; 11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752; 12) HANA TABLE, Pack Number DYNJ908424A; 13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ; 14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ; 15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A; 16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A; 17) LUMBAR DRAIN PACK , Pack Number DYNJ67379; 18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ; 19) OPEN SHOULDER CDS , Pack Number CDS983316D ; 20) ORTHO SPINE PACK, Pack Number DYNJ59720A ; 21) ORTHO SPINE PACK, Pack Number DYNJ59720B ; 22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ; 23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ; 24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ; 25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A; 26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C

Z-2765-2024
Recall number
Z-2765-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ63330B , Lot Number: 23KMB339 ; DYNJ82317, Lot Number: 23JMD184 ; DYNDH1446A , Lot Number: 21LBY820 ; DYNDH1446A , Lot Number: 22GBD333 ; DYNDH1446A , Lot Number: 22JBR587 ; DYNDH1446A , Lot Number: 23FBP838 ; DYNDH1446A , Lot Number: 23GBR825 ; DYNDH1446A , Lot Number: 23HBU128 ; DYNDH1446A , Lot Number: 23IBD510 ; DYNDH1446A , Lot Number: 23JBY402 ; DYNDH1446A , Lot Number: 24ABN001 ; DYNDH1446A , Lot Number: 24BBU148 ; DYNDH1446A , Lot Number: 21BBP451 ; DYNDH1446A , Lot Number: 21BBQ361 ; DYNDH1648, Lot Number: 24CBI888 ; PAIN1396 , Lot Number: 24CMC928 ; DYNDH1648, Lot Number: 23BBU844 ; DYNDH1648, Lot Number: 23FBT610 ; DYNDH1648, Lot Number: 23KBG110 ; DYNDH1648, Lot Number: 23LBH307 ; DYNDH1648, Lot Number: 24BBQ373 ; PAIN1396 , Lot Number: 21HBQ984 ; PAIN1396 , Lot Number: 21LBQ751 ; PAIN1396 , Lot Number: 22BBY990 ; PAIN1396 , Lot Number: 22EBO906 ; PAIN1396 , Lot Number: 22GMH098 ; PAIN1396 , Lot Number: 22JMC249 ; PAIN1396 , Lot Number: 23AMC516 ; DYNJRA2152 , Lot Number: 23FBO275 ; DYNJRA2152 , Lot Number: 24BBP039 ; MNS12670B, Lot Number: 21FBO557 ; DYNJ909699 , Lot Number: 23IBG223 ; DYNJ909699 , Lot Number: 23IBI956 ; DYNDH1752, Lot Number: 22HLA308 ; DYNDH1752, Lot Number: 22KLA526 ; DYNDH1752, Lot Number: 23ELA116 ; DYNDH1752, Lot Number: 23FLA891 ; DYNDH1752, Lot Number: 23HLA148 ; DYNDH1752, Lot Number: 23JLA566 ; DYNJ908424A, Lot Number: 23IBP270 ; DYNJ907481 , Lot Number: 22CBZ144 ; DYNJ907481 , Lot Number: 22JBR781 ; DYNJ907480 , Lot Number: 21LBR978 ; DYNJ907480A, Lot Number: 22GBS401 ; DYNJ907480A, Lot Number: 22HBS464 ; DYNJ907480A, Lot Number: 22KBO665 ; DYNJ907480A, Lot Number: 22LBM801 ; DYNJ907480A, Lot Number: 23ABS425 ; DYNJ907480A, Lot Number: 23BBN787 ; DYNJ907480A, Lot Number: 23JBR354 ; DYNJ907480A, Lot Number: 24ABJ482 ; DYNJ907479A, Lot Number: 22EBM144 ; DYNJ907479A, Lot Number: 22EBN033 ; DYNJ67379, Lot Number: 22OBA461 ; DYNJ67379H , Lot Number: 22OBA461 ; CDS983316D , Lot Number: 21KBZ646 ; CDS983316D , Lot Number: 22GBK913 ; CDS983316D , Lot Number: 22JBP359 ; CDS983316D , Lot Number: 22JBQ356 ; DYNJ59720A , Lot Number: 21LBL971 ; DYNJ59720B , Lot Number: 22GBE154 ; DYNJ59720B , Lot Number: 22HBY469 ; DYNJ59720B , Lot Number: 23FBQ399 ; DYNJ59720B , Lot Number: 23IBL648 ; DYNJ51178D , Lot Number: 23IDA216 ; CDS940845L , Lot Number: 21LBG348 ; CDS940845L , Lot Number: 22GBJ055 ; CDS940845L , Lot Number: 22GBJ056 ; CDS940845L , Lot Number: 22KBH989 ; CDS940845L , Lot Number: 22KBJ721 ; CDS940845L , Lot Number: 22KBJ722 ; DYNJ907028 , Lot Number: 21KBV769 ; DYNJ907028 , Lot Number: 21LBG283 ; DYNJ907028A, Lot Number: 22HBS848 ; DYNJ907028C, Lot Number: 23BBN541 ; DYNJ907028C, Lot Number: 23CBO748 ; DYNJ907028C, Lot Number: 23GBC293 ; DYNJ907028C, Lot Number: 23IBD257 ; DYNJ907028C, Lot Number: 23IBV462

Distribution pattern

Worldwide